(51 days)
The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/ Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.
The Philips EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems are general purpose, software-controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and display it in various modes of operation. They consist of a system console and transducers.
The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a predicate device (Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, K172607). No clinical studies were required.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety and Performance Standards) | Reported Device Performance (Compliance) |
|---|---|
| Acoustic output display requirements of IEC 60601-2-37 Ed 2.0 and IEC 62359. | System and transducers are compliant. |
| FDA ultrasound guidance document: "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 9, 2008). | System complies with the guidance document. |
| Ispta.3 ≤ 720 MW/cm2 | Met (acoustic output limits are within this range). |
| MI < 1.9 | Met (acoustic output limits are within this range). |
| TI < 6.0 | Met (acoustic output limits are within this range). |
| IEC 60601-1: Medical electrical equipment. Basic safety and essential performance, 2005, Amendment 1, 2012. | Compliant. |
| IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014. | Compliant. |
| IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007. | Compliant. |
| IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010. | Compliant. |
| ISO 10993: Biological evaluation of medical devices, 2009. | Compliant. |
| System level requirements and risk control measures (from Appendix M). | Non-clinical verification testing performed. |
| Intended use and commercial claims. | Non-clinical validation testing covered these. |
| Usability. | Usability testing performed with representative intended users. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the document. The document states that "Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users." However, specific sample sizes for these tests are not mentioned.
The data provenance is from Philips Ultrasound, Inc.'s internal testing, as indicated by "Philips Ultrasound performed the following testing to ensure the safety and effectiveness..." It is considered retrospective as it refers to testing already completed to support the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided. Since the evaluation relied on non-clinical performance data and compliance with standards, and no clinical studies were performed, there isn't a "test set" in the context of expert-labeled medical data for algorithm performance. Usability testing involved "representative intended users," but their qualifications or number for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication for ground truth is mentioned. The assessment relied on non-clinical testing and compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No MRMC comparative effectiveness study was mentioned or performed. The submission relies on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical data, not on comparing human reader performance with and without AI assistance. The device is a diagnostic ultrasound system, not an AI-powered diagnostic aid in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not directly applicable in the conventional sense of an AI algorithm's standalone performance. The document describes a diagnostic ultrasound system with expanded features (ElastQ Imaging Linear) and a new transducer (S9-2). The "algorithm" here refers to image processing and diagnostic functions integrated into the ultrasound system itself, not a separate AI-driven software that would have a standalone performance measured against human interpretation. The non-clinical verification and validation testing would cover the performance of these integrated functions.
7. The Type of Ground Truth Used
For compliance with standards like IEC 60601-1, 60601-1-2, 60601-2-37, and 62359, the "ground truth" would be the established specifications and limits defined by these international standards. For non-clinical verification and validation testing, the "ground truth" would be derived from engineering specifications and controlled test conditions designed to evaluate the system's output against known desired performance parameters. For usability testing, the "ground truth" would be user feedback and observed user interactions against predefined usability requirements.
8. The Sample Size for the Training Set
Not applicable. This submission is for a diagnostic ultrasound system, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The development of the ultrasound system's functionalities, including the new ElastQ Imaging Linear mode, would involve internal engineering development and testing, but not a distinct "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this context. The "ground truth" for the device's development and testing would be based on established engineering principles, physics, and international performance and safety standards for medical ultrasound equipment.
{0}------------------------------------------------
July 27, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K181485
Trade/Device Name: EPIQ , EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 17, 2018 Received: July 18, 2018
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K181485
Device Name
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, EPIQ Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Indications for Use (Describe)
The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/ Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where the EPIQ and Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
| CONTINUIF ON A SEPARATE PAGE IF NEEDED | ||||||||
|---|---|---|---|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||||||
| Type of Use (Select one or both, as applicable) |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,15,16,17,18,19 | ||
| Intra-operative (Cardiac) | P | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |
| Intra-operative (Vascular) | P | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,12,13,17,18 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,15,17,19 | ||
| Neonatal Cephalic | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13,17 | ||
| Adult Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,12,13,17 | ||
| Trans-rectal | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,15,17 | ||
| Trans-vaginal | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,15,17 | ||
| Trans-urethral | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,15,17 | ||
| Trans-esoph. (non-Cardiac) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,15,17 | ||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,15,17 | ||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 |
| Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 5,6,8,10,12,13,14 | |
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 |
| Cerebral vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 |
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 10: Harmonic Imaging |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 11: Contrast Imaging |
| Note 2: Combined modes include: B+M+Color | Note 12: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 13: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 14: TDI |
| Note 5: SonoCT | Note 15: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 16: ElastPQ (for Liver) |
| Note 7: Infertility monitoring of follicle development | Note 17: PercuNav |
| Note 8: Panoramic Imaging | Note 18: ElastQ Imaging |
| Note 9: Color Power Angio (CPA) | Note 19: ElastQ Imaging Linear |
| Previous submission: K172607, EPIQ/Affiniti |
{4}------------------------------------------------
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler** | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | ||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,10,11,12,13, 15 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | |||||||
| Other: Urology | P | P | P | P | ||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,12,13 | ||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular |
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: 3D9-3v
Transducer:
N= new indication; P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 10: Harmonic Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 11: Contrast Imaging Note 12: 3D/4D Imaging Note 2: Combined modes include: B+M+Color Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 13: XRES Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 14: TDI Note 5: SonoCT Note 15: Elastography Note 6: Imaging for guidance of biopsy Note 16: ElastPQ (for Liver) Note 7: Infertility monitoring of follicle development Note 17: Percu Nav Note 8: Panoramic Imaging Note 9: Color Power Angio (CPA) Previous Submission: K172607, EPIQ/Affiniti
{5}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: C5-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,16,17,18 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17,18 | ||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11,12,13,17 | ||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note: 5,6,8, 9,10,11,12,13,17 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,6,10,12,13 | ||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| Cerebral vascular | ||||||||
| N= new indication | P= previously cleared | |||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 10: Harmonic Imaging | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 11: Contrast Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 12: 3D/4D Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 13: XRES | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 14: TDI | |||||||
| Note 5: SonoCT | Note 15: Elastography | |||||||
| Note 6: Imaging for guidance of biopsy | Note 16: ElastPQ (for Liver) | |||||||
| Note 7: Infertility monitoring of follicle development | Note 17: PercuNav | |||||||
| Note 8: Panoramic Imaging | Note 18: ElastQ Imaging | |||||||
| Note 9: Color Power Angio (CPA) |
Previous submission: K172607, EPIQ/Affiniti
{6}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: C8-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| Cerebral Vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | ||
| P= previously clearedN= new indicationAdditional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: Percu Nav |
Previous Submission: K172607, EPIQ/Affiniti
{7}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: C9-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | |||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | |||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,6,10,12,13 | |||
| Peripheral | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Vessel | Cerebral Vascular | ||||||||
| N= new indication P= previously cleared | |||||||||
| Additional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,12,13,17 | |||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13, 15,17 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,15,17 | |||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,15,17 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Peripheral vessel | |||||||||
| PeripheralVessel | Cerebral Vascular | ||||||||
| N= new indicationP= previously clearedAdditional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | |||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Color Power Angio (CPA) | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 10: Harmonic Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: Contrast Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 12: 3D/4D Imaging | ||||||||
| Note 5: SonoCT | Note 13: XRES | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 14: TDI | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 15: Elastography | ||||||||
| Note 8: Panoramic Imaging | Note 16: ElastPQ (for Liver) | ||||||||
| Previous Submission: K172607. ΕΡΙQ/Affiniti | |||||||||
| Transducer: C10-4ecIntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | |||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11,12,13,17 | |||
| Trans-vaginal | P | P | P | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,17 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,12,13,17 | |||
| Other: Urology | P | P | P | P | Note: 1,2,3 | Note:5,6,7,8,9,10,11,12,13,17 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | ||
| Cerebral Vascular | |||||||||
| N= new indicationP= previously cleared | |||||||||
| Additional Comments:*Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
Previous submission: K172607, EPIQ/Affiniti
{8}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems Transducer: C10-3v
{9}------------------------------------------------
EPIQ, EPIQ 7, and EPIQ 5 Ultrasound Systems System: Transducer: C10-4ec
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 2: Combined modes include: B+M+Color | Note 10: Harmonic Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: Contrast Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 12: 3D/4D Imaging |
| Note 5: SonoCT | Note 13: XRES |
| Note 6: Imaging for guidance of biopsy | Note 14: TDI |
| Note 7: Infertility monitoring of follicle development | Note 15: Elastography |
| Note 8: Panoramic Imaging | Note 16: ElastPQ (for Liver) |
| Previous Submission: K172607, EPIQ/Affiniti | Note 17: PercuNav |
{10}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: D2cwc
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | ||||||||
| N= new indication P= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{11}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: D2tcd
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | |||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | P | |||||||
| N= new indication P= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Color Power Angio (CPA) | |||||||
| Note 2: Combined modes include: B+M+Color | Note 10: Harmonic Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: Contrast Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 12: 3D/4D Imaging | |||||||
| Note 5: SonoCT | Note 13: XRES | |||||||
| Note 6: Imaging for guidance of biopsy | Note 14: TDI | |||||||
| Note 7: Infertility monitoring of follicle development | Note 15: Elastography | |||||||
| Note 8: Panoramic Imaging | Note 16: ElastPQ (for Liver) | |||||||
| Note 17: PercuNav | ||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{12}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: D5cwc
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | ||||||
| Cerebral Vascular | P | |||||||
| N= new indication P= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{13}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: L12-3 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | P | P | P | P | ||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicle) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | ||
| Neonatal Cephalic | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| Vessel | Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |
| N= new indicationP= previously clearedAdditional Comments: |
*Color Doppler includes Color Amplitude Doppler
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
|---|---|
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note 17: PercuNav |
| Previous Submission: K172607 ERIO/Affiniti |
Note 9: Color Power Angio (CPA)
Previous Submission: K172607, EPIQ/Affiniti
{14}------------------------------------------------
System: EPIQ, EPIQ 5 and EPIQ 7 Ultrasound Systems
Transducer: L12-5 50
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,15,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13, 17 | ||
| Small Organ (breast, thyroid, testicle) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,15,17 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | ||
| N= new indication P= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607. EPIQ/Affiniti |
{15}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:
Transducer: el18-4
s for the more of the bright of the research
Transducer:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| Abdominal | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,15,17,19 | |
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13, 17 | |
| Small Organ (breast, thyroid,testicle) | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,15,17, 18,19 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | ||
| N= new indicationP= previously cleared | ||||||||
| Additional Comments: |
| *Color Doppler includes Color Amplitude Doppler | Note 10: Harmonic Imaging |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 11: Contrast Imaging |
| Note 2: Combined modes include: B+M+Color | Note 12: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 13: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 14: TDI |
| Note 5: SonoCT | Note 15: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 16: ElastPQ (for Liver) |
| Note 7: Infertility monitoring of follicle development | Note 17: PercuNav |
| Note 8: Panoramic Imaging | Note 18: ElastQ Imaging |
| Note 9: Color Power Angio (CPA) | Note 19: ElastQ Imaging Linear |
| Previous Submission: K172607 EPIO/Affiniti |
{16}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: L15-7io Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| Intra-operative (Vascular) | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,2,3 | Note: 5,8,10,12,13 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | ||
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | |||
| N= new indicationP= previously clearedAdditional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav |
{17}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: 118-5
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,12,13,15,17 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | ||
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |||
| N= new indicationP= previously clearedAdditional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{18}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: S5-1
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13, 17 | |||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13,17 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13, 17 | |||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,12,13, 17 | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14, 17 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14, 17 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,13,14 | ||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13, 17 | ||
| Cerebral Vascular | |||||||||
| N= new indicationP= previously clearedAdditional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607. EPIO/Affiniti |
{19}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: S7-3t
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular | |||||||||
| N= new indication P= previously cleared | |||||||||
| Additional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607. EPIO/Affiniti |
{20}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: ട്ടു-3
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 7,8,10,12,13 | |||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 7,8,10,12,13 | |||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,10,12,13 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular | |||||||||
| N= new indicationP= previously cleared | |||||||||
| Additional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607, EPIQ |
{21}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
Transducer: S9-2
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | N | N | N | N | Note: 1,2,3 | Note: 7,8,10,12,13 | ||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note: 1,2,3 | Note: 7,8,10,12,13 | ||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | N | N | N | N | Note: 1,2,3 | Note: 8,10,12,13 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | N | N | N | N | N | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note: 1,2,3,4 | Note: 10,12,13,14 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | N | N | N | N | N | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | ||||||||
| N= new indication P= previously clearedAdditional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | ||||||||
| Note 2: Combined modes include: B+M+Color | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | ||||||||
| Note 5: SonoCT | Note 9: Color Power Angio (CPA) | |||||||
| Note 6: Imaging for guidance of biopsy | ||||||||
| Note 7: Infertility monitoring of follicle development | ||||||||
| Note 8: Panoramic Imaging | Note 10: Harmonic Imaging | |||||||
| Note 11: Contrast Imaging | ||||||||
| Note 12: 3D/4D Imaging | ||||||||
| Note 13: XRES | ||||||||
| Note 14: TDI | ||||||||
| Note 15: Elastography | ||||||||
| Note 16: ElastPQ (for Liver) | ||||||||
| Note 17: PercuNav | ||||||||
| Previous Submission: |
{22}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:
Transducer: S12-4
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 8,10,12,13 | |||
| Small Organ (breast, thyroid, testicle) | |||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,10,12,13 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 12,13,14 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 12,13,14 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular | |||||||||
| N= new indicationP= previously cleared | |||||||||
| Additional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{23}------------------------------------------------
System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems Transducer: V6-2 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other | ||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler* | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,2,3 | Note: 5,9,10,13 | ||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular | |||||||
| N= new indicationP= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{24}------------------------------------------------
System:
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems
VL13-5 Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Fetal Imaging& Other | Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | |||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | ||
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 |
N= new indication; P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: EFOV including Amplitude Doppler |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | |
| Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{25}------------------------------------------------
System: EPIQ EPIQ 5, and EPIQ 7 Ultrasound System
Transducer: X5-1
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,12,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,12,13 | |
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,12,13 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular | |||||||
| N= new indicationP= previously clearedAdditional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{26}------------------------------------------------
System: EPIQ EPIQ 5, and EPIQ 7 Ultrasound System
Transducer: X6-1
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13 | ||
| Abdominal | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,11,12,13,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: ,6,8,9,10,12,13,17 | ||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,2,3 | Note: ,6,8,9,10,12,13 | ||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,11,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 6,8,9,10,12,13,17 | ||
| N= new indicationP= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{27}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound System System:
Transducer: X7-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,2,3 | Note: 6,7,8,10,11,12,13 | ||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,2,3 | Note: 6,7,8,10,12,13 | ||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,13,14 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,13,14 | |
| PeripheralVessel | Peripheral vessel | Note: 1,2,3 | ||||||
| Cerebral Vascular |
N= new indication; P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: EFOV including Amplitude Doppler |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | |
| Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{28}------------------------------------------------
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:
Transducer: X7-2t
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 |
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | ||||||||
| N= new indication P= previously cleared | ||||||||
| Additional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{29}------------------------------------------------
EPIQ and EPIQ 7 Ultrasound System System:
Transducer: X8-2t
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal / OB | |||||||||
| Abdominal | ||||||||||
| Intra-operative (Cardiac) | ||||||||||
| Intra-operative (Vascular) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Conventional) | ||||||||||
| Musculo-skel. (Superficial) | ||||||||||
| Intra-luminal | ||||||||||
| Other: GYN | ||||||||||
| Other: Urology | ||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |||
| Other (Fetal Echo) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral Vascular | ||||||||||
| N= new indication P= previously cleared | ||||||||||
| Additional Comments: | ||||||||||
| *Color Doppler includes Color Amplitude Doppler | ||||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 9: Color Power Angio (CPA) | |||||||||
| Note 2: Combined modes include: B+M+Color | Note 10: Harmonic Imaging | |||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 11: Contrast Imaging | |||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 12: 3D/4D Imaging | |||||||||
| Note 5: SonoCT | Note 13: XRES | |||||||||
| Note 6: Imaging for guidance of biopsy | Note 14: TDI | |||||||||
| Note 7: Infertility monitoring of follicle development | Note 15: Elastography | |||||||||
| Note 8: Panoramic Imaging | Note 16: ElastPQ (for Liver) | |||||||||
| Note 17: PercuNav | ||||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{30}------------------------------------------------
EPIQ and EPIQ 7 Ultrasound System System:
Transducer: S8-3t
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal / OB | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Cardiac) | ||||||||||
| Intra-operative (Vascular) | ||||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid, testicle) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Conventional) | ||||||||||
| Musculo-skel. (Superficial) | ||||||||||
| Intra-luminal | ||||||||||
| Other: GYN | ||||||||||
| Other: Urology | ||||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note 10, 13,14 | ||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |||
| Other (Fetal Echo) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral Vascular | ||||||||||
| N= new indicationP= previously cleared | ||||||||||
| Additional Comments: | ||||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||||
| Note 5: SonoCT | Note 14: TDI | |||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | |||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{31}------------------------------------------------
EPIQ and EPIQ 7 Ultrasound System System: Transducer: X8-2ti Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | ||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular | |||||||||
| N= new indicationP= previously cleared | |||||||||
| Additional Comments: | |||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | ||||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | ||||||||
| Note 5: SonoCT | Note 14: TDI | ||||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | ||||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | ||||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav | ||||||||
| Previous Submission: K172607, EPIQ/Affiniti |
{32}------------------------------------------------
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,17 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,2,3 | Note:5,6,8,9,10,11,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | ||
| N= new indication P= previously clearedAdditional Comments: | ||||||||
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |||||||
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |||||||
| Note 5: SonoCT | Note 14: TDI | |||||||
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |||||||
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |||||||
| Note 8: Panoramic Imaging | Note 17: PercuNav |
Previous Submission: K172607, EPIQ/Affiniti
EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: XL14-3 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{33}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13,15,16,17 | ||
| Intra-operative (Cardiac) | P | P | P | P | Note: 1,3 | Note: 5,8,10,11,12,13 | ||
| Intra-operative (Vascular) | P | P | P | P | Note: 1,3 | Note: 5,8,10,11,12,13 | ||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,15,17 | ||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 5,8,9,10,11,12,13 | ||
| Adult Cephalic | P | P | P | P | Note: 1,3 | Note: 8,10,11,12,13 | ||
| Trans-rectal | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Trans-vaginal | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,15,17 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13, 15,17 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13, 15,17 | ||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 |
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 5,6,8,10,12,13,14 | |
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 |
N= new indication, P=- previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{34}------------------------------------------------
System: Affiniti 70 Ultrasound System C5-1
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,15,16,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,17 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,10,12,13 | ||
| PeripheralVessel | Peripheral Vessel | |||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{35}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: C6-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | |
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13,15 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8, 9,10,11,12,13 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,8, 9,10,11,12,13 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,10,12,13 | ||
| PeripheralVessel | Peripheral Vessel | |||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{36}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: C8-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,11,12,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,11,12,13 | |
| Small Organ (breast, thyroid, | ||||||||
| testicle) | ||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,12,13 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,11,12,13 | |
| Vessel | Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,11,12,13 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{37}------------------------------------------------
System: Affiniti 70 Ultrasound System C9-2
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |||
| Other: Urology | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,10,12,13 | |||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{38}------------------------------------------------
System: Affiniti 70 Ultrasound System
Transducer: C10-3v
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other | ||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler* | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | ||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, thyroid, | ||||||||
| testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,10,11,12,13, 15 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,15 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,15 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,12,13 | ||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{39}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: 3D9-3v
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | ||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, | ||||||||
| testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note: 1,3 | Note: 5,6,7, 8,10,11,12,13 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,12,13 | ||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
Additional Comments: Note 9: Color Power Angio (CPA) *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 2: Combined modes include: B+M+Color Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 12: 3D/4D Imaging Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{40}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: C9-4v
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | |
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | Note: 1,3 | Note: 5,6,7, 8,10,11,12,13, 15 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,15 | ||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,15 | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,12,13 | ||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging Note 12: 3D/4D Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{41}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: C10-4ec
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | ||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | Note: 1,3 | Note: 5,6,7, 8,9,10,11,12,13,17 | |||
| Trans-vaginal | P | P | P | P | Note: 1,3 | Note: 5,6,7, 8,9,10,11,12,13,17 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,17 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,11,12,13 | |||
| PeripheralVessel | Peripheral Vessel | ||||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{42}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: BP10-5ec
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal / OB | ||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,13 | |||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | P | P | P | P | Note: 5,6,8,9,10,11,13 | ||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
Additional Comments: Note 9: Color Power Angio (CPA) *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 2: Combined modes include: B+M+Color Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 12: 3D/4D Imaging Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{43}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: D2cwc
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{44}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: D2tcd
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | |||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{45}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: D5cwc
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | |||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | ||||||
| Cerebral Vascular | P |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{46}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: L12-3
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13 | |||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Vessel | Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{47}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: L12-4
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
N= new indication, P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging Note 12: 3D/4D Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{48}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System
Transducer: L12-5 50
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,15,17 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{49}------------------------------------------------
System: Affiniti 70 Ultrasound System
Transducer: eL18-4
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,17 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,15,17 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,17 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{50}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: L15-7io
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | |||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13 | ||
| Intra-operative (Cardiac) | P | P | P | P | Note: 1,3 | Note: 5,8,9,10,11,12,13 | ||
| Intra-operative (Vascular) | P | P | P | P | Note: 1,3 | Note: 5,8,9,10,11,12,13 | ||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{51}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: L18-5
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,11,12,13 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Musculo-skel. (Superficial) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |
| Vessel | Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{52}------------------------------------------------
System: Affiniti 70 Ultrasound System S5-1
Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,13,17 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, | ||||||||
| testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | Note: 1,3 | Note: 8,9,10,11,13,17 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | Note:17 PercuNav |
| Previous Submission: K172607, EPIQ/Affiniti |
{53}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System S4-2
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 5,6, 8,9,10,11,13 | |||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | Note: 1,3 | Note: 8,9,10,11,13 | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Vessel | Cerebral Vascular |
N= new indication, P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 2: Combined modes include: B+M+Color Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 12: 3D/4D Imaging Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{54}------------------------------------------------
| System: Affiniti 70/50 Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer:Intended Use: | S7-3tDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Mode of Operation (*includes simultaneous B-mode) | |||||||||
| General(Track I only) | Clinical ApplicationSpecific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | |||||||||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | ||
| Other (Fetal Echo) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral Vascular |
N= new indication, P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging Note 12: 3D/4D Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{55}------------------------------------------------
System: Affiniti 70 Ultrasound System
Transducer: 58-31
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 |
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication, P= previously cleared
Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 12: 3D/4D Imaging Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 13: XRES Note 5: SonoCT Note 14: TDI Note 6: Imaging for guidance of biopsy Note 15: Elastography Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K172607, EPIQ/Affiniti
{56}------------------------------------------------
System: Affiniti 70/50/30 Ultrasound System 58-3
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 7,8,9,10,13 | ||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 8,9,10,11,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | P | P | P | P | Note: 1,3 | Note: 8,10,11,13 | |
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 8,10,13 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 |
| Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | P | P | Note: 1,3 | Note: 10,11,13 | |
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular |
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{57}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer:
S12-4
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Intended Use:Clinical Application | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal / OB | |||||||
| Abdominal | P | P | P | P | Note: 1,3 | Note: 8,9,10,11,13 | ||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | Note: 1,3 | Note: 8,9,10,11,13 | |
| Small Organ (breast, thyroid, testicle) | ||||||||
| Neonatal Cephalic | P | P | P | P | Note: 1,3 | Note: 8,9,10,13 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Cerebral Vascular |
N= new indication, P= previously cleared
| Additional Comments: | |
|---|---|
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{58}------------------------------------------------
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
| General | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| (Track I only) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / OB | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |||
| Abdominal | |||||||||
| Intra-operative (Cardiac) | |||||||||
| Intra-operative (Vascular) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other: GYN | |||||||||
| Other: Urology | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (Fetal Echo) | P | P | P | P | Note: 1,3 | Note: 5,9,10,11,13 | |||
| PeripheralVessel | Peripheral vesselCerebral Vascular |
System: Affiniti 70/50/30 Ultrasound System
Transducer: V6-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication, P= previously cleared
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|---|---|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic Imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{59}------------------------------------------------
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular |
System: Affiniti 70/50 Ultrasound System
Transducer: X7-2t
N= new indication, P= previously cleared
| Additional Comments: | ||
|---|---|---|
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) | |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging | |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging | |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging | |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES | |
| Note 5: SonoCT | Note 14: TDI | |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography | |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) | |
| Note 8: Panoramic Imaging | ||
| Previous Submission: K172607, EPIQ/Affiniti |
{60}------------------------------------------------
System: Affiniti 70 Ultrasound System
Transducer: X5-1
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Fetal Imaging& Other | Abdominal | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,13 | |
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| & Other | Pediatric | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,13 | |
| Small Organ (breast, thyroid,testicle) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | Note: 1,2,3 | Note: 8,9,10,13 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,13,14 |
| Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,13,14 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Cerebral Vascular | ||||||||
| N= new indication P= previously cleared | ||||||||
| Additional Comments:*Color Doppler includes Color Amplitude Doppler | ||||||||
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | ||||||||
| Note 2: Combined modes include: B+M+Color | ||||||||
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | ||||||||
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | ||||||||
| Note 5: SonoCT | ||||||||
| Note 6: Imaging for guidance of biopsy | ||||||||
| Note 7: Infertility monitoring of follicle development | ||||||||
| Note 8: Panoramic Imaging | ||||||||
| Previous Submission: K172607, EPIO |
{61}------------------------------------------------
System: Affiniti 70/50 Ultrasound System
Transducer: VL13-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / OB | ||||||||
| Abdominal | ||||||||
| Intra-operative (Cardiac) | ||||||||
| Intra-operative (Vascular) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid,testicle) | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Conventional) | ||||||||
| Musculo-skel. (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other: GYN | ||||||||
| Other: Urology | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 | |
| Cerebral Vascular | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
N= new indication, P= previously cleared
| Additional Comments: | |
|---|---|
| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 10: Harmonic Imaging |
| Note 2: Combined modes include: B+M+Color | Note 11: Contrast Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 13: XRES |
| Note 5: SonoCT | Note 14: TDI |
| Note 6: Imaging for guidance of biopsy | Note 15: Elastography |
| Note 7: Infertility monitoring of follicle development | Note 16: ElastPQ (for Liver) |
| Note 8: Panoramic imaging | |
| Previous Submission: K172607, EPIQ/Affiniti |
{62}------------------------------------------------
510(k) Summary of Safety and Effectiveness
EPIQ and Affiniti Diagnostic Ultrasound Systems
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92
-
- Submitter's name, address, telephone number, contact person.
Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
- Submitter's name, address, telephone number, contact person.
| Contact person: Kym Rupp, Senior Regulatory Affairs Specialist- |
|---|
| Email: kym.rupp@philips.com |
| Tel: 425-487-7127 |
| Fax: 425-487-8666 |
April 23rd, 2018 Date prepared:
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common/usual name: | Diagnostic ultrasound system and transducers |
|---|---|
| Proprietary name: | EPIQ Diagnostic Ultrasound System |
| EPIQ 7 Diagnostic Ultrasound System | |
| EPIQ 5 Diagnostic Ultrasound System | |
| Affiniti 70 Diagnostic Ultrasound System | |
| Affiniti 50 Diagnostic Ultrasound System | |
| Affiniti 30 Diagnostic Ultrasound System |
These devices are classified as follows:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
As stated in 21 CFR, parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.
{63}------------------------------------------------
| Philips Ultrasound, Inc. | Traditional 510(k)EPIQ and Affiniti DiagnosticUltrasound Systems | Page 46 of 150 |
|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | ---------------- |
3. Substantially Equivalent Devices
Philips Ultrasound believes the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are substantially equivalent to the following currently marketed devices:
| Predicate Device | 510(k) |
|---|---|
| Philips EPIQ Diagnostic Ultrasound System and PhilipsAffiniti Diagnostic Ultrasound System | K172607 |
4. Device Description
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.
5. Indications for Use
The intended use of the EPIQ, EPIO 5, EPIO7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the follow Indications for Use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where the EPIQ and Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user
{64}------------------------------------------------
information reduces your responsibility for sound clinical judgement and best clinical procedure.
6. Technological Comparison to Predicate Devices
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems and the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System (K172607), employ the same fundamental scientific technology. The primary differences are the addition of the S9-2 transducer to the EPIQ Diagnostic Ultrasound Systems and the extended use of ElastQ Imaging Linear (Shear Wave Elastography Imaging). The main difference between ElastO Imaging and the new ElastQ Imaging Linear is summarized below:
- ElastQ Linear enables a different scanning geometry. The cleared ElastQ Imaging uses curvilinear scanning geometry while Elast() Imaging Linear uses Linear scanning geometry to allow for additional transducers to be used.
- . The proposed ElastQ Imaging Linear has a higher spatial resolution which supports a stiffness range 0-200kPa (0-8.2 m/s). The cleared ElastO Imaging supports a stiffness range of 0-90kPa (0-5.5 m/s). This expanded tissue stiffness range allows for measurements of the breast in addition to the abdomen.
- The proposed ElastQ Imaging Linear offers a visual comparison between ● compression elastography and Elast() Linear images, which was not available on the currently cleared ElastQ Imaging
A comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIO Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System is provided in Table 1 below:
Table 1 Comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System.
| StandardFeature | EPIQK172607 (Predicate Device) | EPIQ 3.0(Proposed Device) | AffinitiK172607(Predicate Device) | Affiniti 3.0(ProposedDevice) |
|---|---|---|---|---|
| Indicationsfor Use | Fetal/Obstetric,Abdominal,Intraoperative (Vascular),Intraoperative (Cardiac),Pediatric, Small Organ (Breast,Thyroid, Testicle),Cephalic (Neonatal),Cephalic (Adult),Transrectal, Transvaginal | Same as EPIQK172607 | Same as EPIQK172607 | Same as EPIQK172607 |
{65}------------------------------------------------
| Musculoskeletal (Conventional),Musculoskeletal (Superficial)Gynecological, Other: Urology,Cardiac Adult,Cardiac Pediatric,Transesophageal (Cardiac),Cardiac other (Fetal),Peripheral Vessel, CerebralVascular, | ||||
|---|---|---|---|---|
| Transducers | C5-1, C8-5, C9-2, C10-3v, C10-4ec, D2cwc, D5cwc, eL18-4, L12-3, L12-5 50, L15-7io, L18-5, S5-1,S7-3t, S8-3, S8-3t, S12-4, V6-2,X7-2t, X8-2t, D2tcd, X5-1, X6-1,VL13-5, X7-2, X8-2ti, XL14-3,3D9-3v | Same as EPIQK172607 withaddition of the S9-2transducer. | 3D9-3v, C5-1, C6-2,C8-5,C9-2, C9-4V,C10-3v, C10-4ec,D2cwc, D2tcd,D5cwc, BP10-5ec,eL18-4, L12-3, L12-4, L12-5 50, L15-7io,L18-5, S4-2, S5-1,S7-3t, S8-3, S12-4,V6-2, VL13-5, X7-2t | Same as AffinitiK172607 |
| TransducerTypes | Phased array Linear array Curved array Pencil Probes Multi-plane Transesophageal Motorized arrays 3D Matrix Array | Same as EPIQK172607 | Phased array Linear array Curved array Pencil Probes Multi-planeTransesophageal Motorizedarrays | Same as AffinitiK172607 |
| TransducerFrequency | 1.0 - 18.0 MHz | Same | Same | Same |
| AcousticOutputDisplay &FDA Limits | IEC 62359 ISPTA max=720 mw/cm2 MI max =1.9 MI display TI display | Same | Same | Same |
| ImagingMode | B mode, M mode, PWD, CWD,Color Doppler, Combined modes, | Same | Same | Same |
| Shear wave | ElastPQ | Same | Same | Same |
| Elastography | ElastQ Imaging | Same with theaddition of ElastQImaging Linear | NA | NA |
| # TransmitChannels | 128 | Same | Same | Same |
| # ReceiveChannels | 256 | Same | Same | Same |
| 510(k) Track | Track 3 | Same | Same | Same |
| ProductSafetyCertification | IEC 60601-1C22.2 No. 60601-1ANSI/AAMI ES60601-1IEC 60601-2-37 | Same | Same | Same |
| EMCCompliance | IEC 60601-1-2 | Same | Same | Same |
{66}------------------------------------------------
| Philips Ultrasound, Inc. | Traditional 510(k)EPIQ and Affiniti DiagnosticUltrasound Systems | Page 49 of 15 |
|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | --------------- |
| PatientContactMaterials | No changes from EPIQ K172607 | |||
|---|---|---|---|---|
| Accessories | Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB PercuNav Instruments Biopsy guides Footswitch | Same | Same | Same |
7. Safety Considerations
As a Track 3 ultrasound device, the subject EPIQ and Affiniti Diagnostic Ultrasound Systems are designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.0 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) and IEC 62359, Ed 2.0 (Ultrasonics -Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields).
The subject EPIQ and Affiniti Diagnostic Ultrasound Systems comply with the referenced standard as well as the FDA ultrasound guidance document. Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on September 9, 2008.
The system acoustic output limits are:
- Ispta.3 ≤ 720 MW/cm2 ●
- MI < 1.9
- TI < 6.0 ●
The system and transducers are compliant to:
- IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- . IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
- IEC 62359, Ultrasonics Field characterization Test methods for the ● determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
-
- Nonclinical Performance Data
{67}------------------------------------------------
Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems:
- IEC 60601-1: Medical electrical equipment. General requirements for basic . safety and essential performance, 2005, Amendment 1, 2012
- . IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the ● basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
- IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
- ISO 10993: Biological evaluation of medical devices, 2009. ●
The proposed EPIO and Affiniti Diagnostic Ultrasound Systems also comply with the FDA ultrasound specific guidance, Guidance for Industry and FDA Staff -Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).
Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.
All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems:
- . comply with the aforementioned international and FDA-recognized consensus standards and FDA ultrasound guidance document, and
- meet the acceptance criteria and are adequate for their intended use. .
Therefore, the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are substantially equivalent to the predicate EPIQ and Affiniti Diagnostic Ultrasound Systems in terms of safety and effectiveness.
Quality assurance measures applied to the system design and development include, but were not limited to:
- Risk Analysis
- Product Specifications ●
- Design Reviews
- Verification and Validation
{68}------------------------------------------------
9. Clinical Data
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems did not require clinical studies since substantial equivalence to the currently marketed predicate devices, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, was demonstrated with the following attributes:
- Design features;
- Indication for use; ●
- Fundamental scientific technology;
- Non-clinical performance testing; and
- Safety and effectiveness. ●
10. Conclusion
The proposed EPIO and Affiniti Diagnostic Ultrasound Systems with the expanded use of ElastQ Imaging Linear mode and the new S9-2 transducer are substantially equivalent with regards to safety and effectiveness to the currently marketed predicate devices, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System and Philips as follows:
- The predicate device and the proposed EPIQ and Affiniti Diagnostic ● Ultrasound Systems are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic ● Ultrasound Systems have the same gray-scale and Doppler capabilities.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic ● Ultrasound Systems use essentially the same technologies for imaging, Doppler functions and signal processing.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic ● Ultrasound Systems have acoustic output levels within the Track 3 FDA limits.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic ● Ultrasound Systems are manufactured under equivalent quality systems.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are manufactured of materials with equivalent bio safety.
- The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are designed and manufactured to the same electrical and physical safety standards.
514 Performance Standards
There are no Sec. 514 performance standards for the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems.
Prescription Status
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are prescription devices. The prescription device statement appears in the labeling.
{69}------------------------------------------------
| Philips Ultrasound, Inc. | Traditional 510(k)EPIQ and Affiniti DiagnosticUltrasound Systems | Page 52 of 150 |
|---|---|---|
| -------------------------- | -------------------------------------------------------------------------- | ---------------- |
Sterilization Sites
Not applicable. No components are supplied sterile.
Track
The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are Track 3 systems.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.