(61 days)
The SonoScape S45 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape S45 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
This document describes the SonoScape S45 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S50 Digital Color Doppler Ultrasound System K152854). The information provided focuses on the regulatory clearance process rather than specific performance metrics against defined acceptance criteria from a clinical study.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this document in the way they would be for an AI/ML device focusing on diagnostic accuracy. The document focuses on demonstrating that the device is safe and effective as an ultrasound system and is substantially equivalent to a previously cleared device.
However, I can extract information related to the device's technical characteristics and the non-clinical tests performed.
Here's an attempt to answer your questions based on the provided text, with clarifications where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for a clinical application. Instead, it focuses on demonstrating compliance with recognized electrical, mechanical, and safety standards for medical ultrasound equipment. The "reported device performance" is framed in terms of meeting these engineering and safety standards and having comparable functionality to the predicate device.
| Category | Acceptance Criteria (as implied by the document) | Reported Device Performance (as implied by the document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:12005+A1:2012 (Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance). | S45 system has been designed and manufactured to meet this standard. |
| EMC | Compliance with IEC 60601-1-2:2007 (Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests). | S45 system has been designed and manufactured to meet this standard. |
| Ultrasound Specific Safety | Compliance with IEC 60601-2-37:2007 (Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment). | S45 system has been designed and manufactured to meet this standard. |
| Biocompatibility | Compliance with ISO 10993-5:2009 (Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity) and ISO 10993-10:2010 (Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization). | S45 system has been designed and manufactured to meet these standards. |
| Acoustic Output | Compliance with AIUM/NEMA UD 2:2004 (R2009) (Acoustic output measurement standard for diagnostic ultrasound equipment) and AIUM/NEMA UD 3:2004 (R2009) (Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment). | S45 system has been designed and manufactured to meet these standards; "consistent acoustic output levels" compared to predicate. |
| Design Specifications | Met all internal design specifications. | Laboratory tests (including Phantom tests) were conducted to verify that the S45 system met all design specifications. System functions and modes are comparable to predicate. |
| Intended Use | The system should be suitable for evaluation across various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal, Cardiac, Trans-esophageal Cardiac, Laparoscopic, OB/Gyn and Urology). | The S45 system has the "same intended use" as the predicate device SonoScape S50 (K152854). |
| Technical Characteristics | Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Conditions should be comparable to the predicate device. | The basic and key technical features of the S45 are the "same as the predicate device." |
| Probes | New probes should have comparable clinical application, performance, and frequency, without affecting safety, effectiveness, or clinical use compared to existing cleared probes. | One new probe (9L-A) was compared to a similar probe (L743) on the predicate device and found to have "same clinical application, similar performance or frequency," and "doesn't affect the safety, effectiveness and clinical use." All other probes are directly equivalent or similar. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical testing was required." Therefore, there is no clinical test set, sample size, or data provenance relevant to clinical performance for this submission. The testing performed was non-clinical (laboratory and phantom tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was required, no experts were used to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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
Not applicable. This device is an ultrasound system, not an AI/ML diagnostic tool meant to assist human readers in image interpretation. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm for standalone diagnostic performance. It is a diagnostic ultrasound system. The "performance" reviewed was its technical and safety compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by engineering specifications, physical phantom measurements, and compliance with the relevant international safety and performance standards for ultrasound equipment. For instance, phantom tests would use known physical properties of the phantom as ground truth.
8. The sample size for the training set
Not applicable, as the document does not describe an AI/ML algorithm with a training set. This is a conventional ultrasound system.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI/ML training set in the document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
SONOSCAPE MEDICAL CORP. Toki Wu 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road Nanshan, Shenzhen 518051, Guangdong CHINA
Re: K160283 Trade/Device Name: S45 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2016 Received: February 1, 2016
Dear Ms. Wu:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160283
Device Name
S45 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape S45 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
SonoScape S45 System:
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes2,4,5,6,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,4 | |
| Cerebral vascular | N |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{4}------------------------------------------------
Transducer: C322 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{5}------------------------------------------------
Transducer: C542 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| FetalImaging&Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{6}------------------------------------------------
Transducer: 3C-A Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{7}------------------------------------------------
Transducer: C1-6 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationGeneral(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{8}------------------------------------------------
Transducer: VC6-2 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4,5 | |||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4,5 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4,5 | |||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{9}------------------------------------------------
Transducer: C613 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{10}------------------------------------------------
Transducer: 5P2 Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{11}------------------------------------------------
Transducer: 8P1 Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Note 7: Elastography
Note 5: 4D
{12}------------------------------------------------
Transducer: 4P-A Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{13}------------------------------------------------
Transducer: S1-5 Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Fetal | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{14}------------------------------------------------
Transducer: 7P-A Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{15}------------------------------------------------
Transducer: L742 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{16}------------------------------------------------
Transducer: L743 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{17}------------------------------------------------
Transducer: L752 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes2,4,6,7 | ||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{18}------------------------------------------------
Transducer: 1012 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| FetalImaging&Other | Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{19}------------------------------------------------
Transducer: 9L-A Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{20}------------------------------------------------
Transducer: 12L-A Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{21}------------------------------------------------
Transducer: VL12-5 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes2,4,5,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
P = previously cleared by FDA; N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{22}------------------------------------------------
Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{23}------------------------------------------------
Transducer: 6V3 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{24}------------------------------------------------
Transducer: 6V7 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{25}------------------------------------------------
Transducer: 6V1A Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
Note 7: Elastography
Note 3: TDI
{26}------------------------------------------------
Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{27}------------------------------------------------
Transducer: BCC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{28}------------------------------------------------
Transducer: BCL10-5 Biplane Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{29}------------------------------------------------
Transducer: VE9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| FetalImaging&Other | Trans-rectal | P | P | P | P | P | Note 1 | Notes2,4,5 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes2,4,5 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes2,4,5 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{30}------------------------------------------------
Transducer: MPTEE Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note 1 | Notes2,3,4 |
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{31}------------------------------------------------
Transducer: MPTEE mini Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note 1 | Notes2,3,4 |
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{32}------------------------------------------------
Transducer: LAP7 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Note 7: Elastography
Note 5: 4D
t use control.
Note 5: 4D
{33}------------------------------------------------
Transducer: CWD2.0
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | Cardiac Pediatric | P | |||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{34}------------------------------------------------
Transducer: PWD2.0
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | P | ||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular | P |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
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510(k) Summary
1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SONOSCAPE MEDICAL CORP. |
|---|---|
| Address: | 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, |
| Nanshan, Shenzhen 518051, Guangdong, China | |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | ra@sonoscape.net |
| Date Prepared | January 22, 2016 |
2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | S45 Digital Color Doppler Ultrasound System |
|---|---|
| Common Name: | Diagnostic Ultrasound System and Transducers |
Classification Regulatory:
| FR Number | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Classification Panel: Radiology Device Class: ll
3. Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate device within this submission is as follows: SonoScape S50 Digital Color Doppler Ultrasound System K152854
4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape S45 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of
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anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
5. Intended Use [21 CFR 807.92(a) (5)]
The SonoScape S45 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]
S45 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape S50 Digital Color Doppler Ultrasound System K152854
Intended Use Comparison:
Compared with the predicate device SonoScape S50 (K152854), the Subject Device S45 has the same intended use.
Technical Characteristics Comparison:
The basic and key technical features of the Subject Device S45 are the same as the predicate device SonoScape S50 (K152854), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition.
The detailed technical features can be found in General Device Descriptions of this submission.
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Probes Comparison:
Subject device S45 has the similar probes as the predicate device SonoScape S50 (K152854).
| Subject deviceSonoScape S45 | Predicate DeviceSonoScape S50 (K152854) | Remark |
|---|---|---|
| C322 Micro-curved Array | C322 Micro-curved Array | |
| C542 Curved Array | C542 Curved Array | |
| 3C-A Curved Array | 3C-A Curved Array | |
| C1-6 Curved Array | C1-6 Curved Array | |
| VC6-2 Curved Array | VC6-2 Curved Array | |
| C613 Micro-curved Array | C613 Micro-curved Array | |
| 5P2 Phased Array | 5P2 Phased Array | |
| 8P1 Phased Array | 8P1 Phased Array | |
| 4P-A Phased Array | 4P-A Phased Array | |
| S1-5 Phased Array | S1-5 Phased Array | |
| 7P-A Phased Array | 7P-A Phased Array | |
| L742 Linear Array | L742 Linear Array | |
| L743 Linear Array | L743 Linear Array | |
| L752 Linear Array | L752 Linear Array | |
| 1012 Linear Array | 1012 Linear Array | |
| 9L-A Linear Array | 12L-A Linear Array | |
| 12L-A Linear Array | VL12-5 Linear Array | SE |
| VL12-5 Linear Array | Analysis1 | |
| 6V1 Micro-curved Array | 6V1 Micro-curved Array | |
| 6V3 Micro-curved Array | 6V3 Micro-curved Array | |
| 6V7 Micro-curved Array | 6V7 Micro-curved Array | |
| 6V1A Micro-curved Array | 6V1A Micro-curved Array | |
| EC9-5 Micro-curved Array | EC9-5 Micro-curved Array | |
| BCC9-5 Micro-curved Array | BCC9-5 Micro-curved Array | |
| BCL10-5 Biplane (Micro-curved + Linear Array) | BCL10-5 Biplane (Micro-curved + Linear Array) | |
| VE9-5 Micro-curved Array | VE9-5 Micro-curved Array | |
| MPTEE Phased Array(Multi-plane) | MPTEE Phased Array(Multi-plane) | |
| MPTEE mini Phased Array(Multi-plane) | MPTEE mini Phased Array(Multi-plane) | |
| LAP7 Linear Array | LAP7 Linear Array | |
| CWD2.0 CW | CWD2.0 CW | |
| PWD2.0 TCD | PWD2.0 TCD |
Table 1 Probes Comparison
SE Analysis 1:
510(k) Summary
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Compared with the predicate device, there is a new probe (9L-A), which is similar with the probe L743 cleared with predicate device SonoScape S50 (K152854). The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use.
Note: detailed description information about the new probe can be found in Substantial Equivalence Comparison of this submission.
Moreover, compared with predicate device, the subject device (S45) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
7. Non-Clinical Tests [21 CFR 807.92(b) (1)]
The S45 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
Laboratory tests (including Phantom tests) were conducted to verify that the S45 system met all design specifications and the S45 system conformed to applicable medical device standards.
The S45 system has been designed and manufactured to meet the following standards: IEC 60601-1:12005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance [08/20/2012];
IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests [03/30/2007];
IEC 60601-2-37:2007, Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [08/09/2007];
ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity [06/01/2009];
ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization [08/01/2010];
AIUM/NEMA UD 2:2004 (R2009), Acoustic output measurement standard for diagnostic ultrasound equipment [08/21/2009]; and
AIUM/NEMA UD 3:2004 (R2009), Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment [08/13/2010].
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8. Clinical Test [21 CFR 807.92(b) (2)]
No clinical testing was required.
9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]
In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that S45 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.
§ 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.