(119 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and imaging modes.
No
The device is described as an "ultrasound imaging system" used to perform "non-invasive diagnostic general purpose ultrasound imaging studies." Its intended use is for imaging and measurement of anatomical structures, which are diagnostic rather than therapeutic actions.
Yes
The "Intended Use / Indications for Use" section states: "The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs... The system also provides the ability to measure anatomical structures". Furthermore, the "Device Description" mentions that it is "used to perform non-invasive diagnostic general purpose ultrasound imaging studies". These phrases clearly indicate that the device is intended for diagnostic purposes.
No
The device description explicitly states it is a "cart based ultrasound imaging system" and mentions hardware components like a scan converter, transducers, LCD monitor, and control panel. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the system for various ultrasound imaging applications and measurements of anatomical structures. This is consistent with a medical imaging device used in vivo (on a living patient).
- Device Description: The description details a cart-based ultrasound imaging system with transducers, a monitor, and controls for performing non-invasive diagnostic ultrasound studies. This is the typical description of an ultrasound machine used for imaging the inside of the body.
- Input Imaging Modality: The input modality is Ultrasound, which is an imaging technique used on living subjects.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
The SuperSonic Imagine AIXPLORER® ultrasound system is used to image the inside of a living patient, not to examine specimens in vitro. Therefore, it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Non-invasive Cardiac, Fetal/Obstetrics.
Indicated Patient Age Range
Neonatal/Adult Cephalic, Pediatric, Fetal/Obstetrics. Specific age ranges are not explicitly defined beyond these categories.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.
In addition to the referenced standards testing, performance tests were conducted with respect to new transducers (XC6-1, SEV12-3 and SL18-5).
The above testing confirmed that the Aixplorer® System performs according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® System to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142100, K132274, K133905, K133761
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like design representing the snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
SuperSonic Imagine, S.A. % Mr. Jacques Souquet Chief Innovation Officer Les Jardins de la Duranne - Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex FRANCE
Re: K161999
Trade/Device Name: AIXPLORER® Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 8, 2016 Received: November 9, 2016
Dear Mr. Souquet:
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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 O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161999
Device Name
AIXPLORER® Ultrasound Diagnostic System
Indications for Use (Describe)
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Druq 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
510(k) number (if known):
Device Name: AIXPLORÉR® Ultrasound System
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined (Specify) | Other* (Specify) |
|---------------------------|---------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|---------------------------------------|
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P, 1, 3, 4, 11 | P, 5, 6, 10 |
| Fetal Imaging &
Other | Fetal | P | N | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10, 11 - N
13,14 |
| | Intra-operative (Specify) vascular,
abdominal, small organs | P | | P | | P | P, 1, 3, 4 | P, 5, 6, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 |
| | Small Organ (Breast, Thyroid,
Testicle, Prostate, penis, etc...) | P | P | P | P | P | P, 1, 2, 3, 4 - N 12 | P, 5, 6, 7, 8, 9, 10- N 14 |
| | Neonatal Cephalic | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 |
| | Adult Cephalic | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6 |
| | Trans-rectal | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5,6, 7, 8 |
| | Trans-vaginal | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 - N 10, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 - N14 |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 - N14 |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 |
| | Pelvic | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N 1, 3, 4, 5, 11 | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9, 10 |
| | Other (Specify) | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Eastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™Eastography
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow +
Shearw ave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
4
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Diagnostic Ultrasound Indications for Use
510(k) Number (if known):
Device Name: SL15-4 transducer (1D Linear Array Transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined (Specify) | Other* (Specify) | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & Fetal | ||||||||
| Other | Abdominal | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N14 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | |||
| Small Organ (for example Breast, | ||||||||
| Thyroid, Testicle, Prostate, Penis) | P | P | P | P 1, 2, 3, 4 - N12 | P 5, 6, 7, 8, 9 - N14 | |||
| Neonatal Cephalic | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N14 | |||
| Musculo-skeletal (Superficial) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N14 | |||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P 1, 3, 4 | P 5, 6, 8, 9 | ||
| Vessel | Other (Specify) | N | N | N | N 1, 3, 4 | N 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging
- 3D Imaging
- Combined modes include: B + M mode
11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Eastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
5
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use
510(k) Number (if known):
Device Name: SC6-1 transducer (curved array transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | P | P | P | P | P, 1, 3, 4, 11 | P, 5, 6 | |
| Other | Abdominal (including urology) | P | N | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N11 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | |||
| Small Organ (Breast, Thyroid, Testicle, | ||||||||
| Prostate, penis, etc...) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | |||
| Musculo-skeletal (Superficial) | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | |||
| Intravascular | ||||||||
| GYN | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |||
| Pelvic | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P 1, 3, 4 | P 5, 6, 8, 9 | ||
| Other (Specify) | P | P | P | P 1, 3, 4 | P 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
™
6: Spatial Compounding
7: ShearWave"MElastography
8: Imaging Guidance for Biopsies
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
| Prescription Use | X | AND/OR |
|---|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
6
510(k) Number (if known):
Device Name: SE12-3 transducer (endocavitary transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | P | P | P | P | P 1, 3, 4, 11 | P 5, 6 | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (for example Breast, Thyroid, | |||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |||
| Trans-vaginal | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 11 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| GYN | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 11 | |||
| Pelvic | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 11 | |||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P 1, 3, 4 | P 5, 6, 8 | |||
| Other (Specify) | P |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Eastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
ShearWave
™
Elastography
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
7
510(k) Number (if known):
Device Name: SLV16-5 transducer (motorized linear transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | ||
| Small Organ (for example Breast, | ||||||||
| Thyroid, Testicle, Prostate, penis, | ||||||||
| etc...) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P 1, 3, 4 | P 5, 6, 8, 9, 10 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
AND/OR
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
12: Combined modes include: Color flow +Shearw ave™ Eastography
11: Combined modes include: B+ M modes
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
9: Panoramic Imaging
8
510(k) Number (if known):
Device Name: SL10-2 transducer (linear transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other* (Specify) |
|---------------------------|---------------------------------------------------------------------------------|---|---|-----|-----|------------------|-----------------------|----------------------------|
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N 13,14 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 |
| | Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...) | P | P | | P | P | P, 1, 2, 3, 4
N 12 | P, 5, 6, 7, 8, 9 - N14 |
| | Neonatal Cephalic | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N14 |
| | Musculo-skeletal (Superficial) | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N14 |
| | Intravascular | | | | | | | |
| | GYN | | | | | | | |
| | Pelvic | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 |
| | Other (Specify) | P | P | | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 |
| | N = new indication; P = previously cleared by FDA (K142100) | | | | | | | |
Additional Comments:
Additional Comments:
1: Combined modes include: B
1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
- Combined modes include: B+ Shear wave Elastic
- Combined modes include: B+ Pulse Wave
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™Elastography
7: Shearwave Elastography
8: Imaging Guide for Biopsy
8: Imaging Guidance for Biopsies
12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)
9: Panoramic Imaging
g
: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
11: Combined modes include: B+ M modes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
9
510(k) Number (if known):
Device Name: SMC12-3 transducer (micro-curved transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Neonatal Cephalic | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | |
| Other (Specify) | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Eastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
10
510(k) Number (if known):
Device Name: XP5-1 transducer (Phased Array transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P | P | P | P 1, 3, 4 | P 5, 6 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P 1, 3, 4 | P 5, 6 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P 1, 3, 4 | P 5, 6 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N 1, 3, 4, 5, | |
| 11 | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P 1, 3, 4 | P 5, 6 | |
| Other (Specify) | P | P | P | P | P 1, 3, 4 | P 5, 6 | ||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) Vascular, | ||||||||
| abdominal, small organs | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 - N 2, 7 | ||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 - N 2, 7 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 - N 2, 7 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 - N 2, 7 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 | |
| Other (Specify) | P | P | P | P | P 1, 3, 4 | P 5, 6, 9 | ||
| N = new indication; P = previously cleared by FDA (K142100) | ||||||||
| Additional Comments: | ||||||||
| 1: Combined modes include: B+ Color Flow | ||||||||
| 2: Combined modes include: B+ ShearWave™ Elastography | ||||||||
| 3: Combined modes include: B+ Pulsed Wave | ||||||||
| 4: Combined modes include: B+ Pulsed Wave + Color Flow | ||||||||
| 5: Harmonic Imaging | ||||||||
| 6: Spatial Compounding | ||||||||
| 7: ShearWave™ Elastography | 9: Panoramic Imaging | |||||||
| 10: 3D Imaging | ||||||||
| 11: Combined modes include: B+ M modes | ||||||||
| 12: Combined modes include: Color flow + Shearwave™ Elastography | ||||||||
| 13: CEUS (Contrast Enhancement UltraSound) | ||||||||
| 14: Angio PL.U.S (Color Doppler improvement) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | N | N | N | N | N, 1, 3, 4, 11 | N, 5, 6 | |
| Abdominal (including urolology) | N | N | N | N | N 1, 2, 3, 4, | |||
| 11 | N 5, 6, 7, 8, 9, 13,14 | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 13 | ||
| Small Organ (Breast, Thyroid, Testicle, | ||||||||
| Prostate, penis, etc...) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8,14 | ||
| Pelvic | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 14 | ||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 | |
| Other (Specify) | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 |
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
- 9: Panoramic Imaging
- 11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Eastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
11
510(k) Number (if known):
Prescription Use X
(Part 21 CFR 801 Subpart D)
Device Name: SLH20-6 transducer (linear transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use (21 CFR 807 Subpart C)
AND/OR
12
510(k) Number (if known):
Device Name: XC6-1 transducer (curved array transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™Elastography
7: Shearwave """ Elastograph
8: Imaging Guidance for Biopsies
11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Eastography
9: Panoramic Imaging
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
13
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use
510(k) Number (if known):
Device Name: SEV12-3 transducer (endocavitary transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | |||||||
| (Track 1 Only) | Specific | ||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||
| Doppler | Other* | ||||||
| (Specify) | |||||||
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging & | |||||||
| Other | Fetal | N | N | N | N | N, 1, 3, 4, 11 | N, 5, 6, 10 |
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (for example Breast, Thyroid, Testicle, | |||||||
| Prostate, penis, etc...) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, | |
| 10 | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, | |
| 10 | |||||||
| Trans-vaginal | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, | |
| 10 | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| GYN | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, | |
| 10 | |||||||
| Pelvic | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, | |
| 10 | |||||||
| Other (Specify) | |||||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| Peripheral | |||||||
| Vessel | Peripheral vessel | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Eastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
™
6: Spatial Compounding
7: ShearWave™Elastography
8: Imaging Guidance for Biopsies
11: Combined modes include: B+ M modes
9: Panoramic Imaging
12: Combined modes include: Color flow +Shearw ave™ Eastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
14
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Diagnostic Ultrasound Indications for Use
510(k) Number (if known):
Device Name: SL18-5 transducer (1D Linear Array Transducer)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 14 |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9 | |
| Small Organ (for example Breast, | ||||||||
| Thyroid, Testicle, Prostate, Penis) | N | N | N | N | N | N 1, 2, 3, 4 | ||
| N 12 | N 5, 6, 7, 8, 9, 14 | |||||||
| Neonatal Cephalic | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 9 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,14 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,14 | |
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8, 9 |
| Vessel | Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™Eastography
8: Imaging Guidance for Biopsies
Prescription Use X (Part 21 CFR 801 Subpart D)
y 10. 3D imaging
11. Combined mo
AND/OR
9: Panoramic Imaging 11: Combined modes include: B+ M modes
12: Combined modes include: Color flow +Shearw ave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
b
Over-The-Counter Use
(21 CFR 807 Subpart C)
15
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
16
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.
- Submitter's name, address, telephone number, contact person Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne – Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24
Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: +1(954) 660 3528
Corresponding Official:
Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35
Date: 2016/06/30
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, if known:
Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: AIXPLORER® Ultrasound Diagnostic System
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, if known:
Classification:
Regulatory Class: II
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| Classification Name: | 21 CFR Section | Product Code | | Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Toshiba
Device
(predicate) | Esaote
Device
(predicate) | SuperSonic Imagine
AIXPLORER®
(predicate) | SuperSonic
Imagine
AIXPLORER®
(predicate) | SuperSonic
Imagine
AIXPLORER®
(new device) |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | 510(k) Number | K133761 | K133905 | K142100 | K132274 | Unassigned |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | Classification
Name | Ultrasonic Pulsed Doppler Imaging
System (892.1550)
Ultrasonic Pulsed Echo Imaging
System (892.1560)
Diagnostic Ultrasound Transducer
(892.1570) | Identical | Identical | Identical | Identical |
| Class | Class II | Identical | Identical | Identical | Identical | | | |
| Intended Use | --- | --- | --- | Diagnostic
ultrasound
imaging, soft
tissue elasticity
imaging, fluid
flow analysis of
the human
body. | Identical | | | |
| General
Description | General purpose, mobile, software
controlled diagnostic ultrasound
system. To acquire ultrasound
data and to display the data in
various modes of operation. | Identical | Identical | Identical | Identical | | | |
3) Substantially Equivalent/Predicate Devices
AIXPLORER® Ultrasound Imaging System (K142100), cleared on 11/20/2014 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Esaote S.p.A Ultrasound Imaging System (K133905), cleared on 04/15/2014 Toshiba System, Diagnostic Ultrasound (K133761), cleared on 22/04/2014
4) Description of Device
The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.
5) Intended Use
The SuperSonic Imagine AIXPLORER® ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AXPLORER® utrasound diagnostic system is in the following applications: Abdominal, Small Urgans, Musculoskeletal, Superficial Musculosketal, Vascular, Intraperative, OB-GYN, Pelvic, Pediatic, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
The system also provides the ability to measure anatomical, Small Organs, Musculoskeletal, Superficial Musculoskeleta, Peripheral Vascular, Intraperative, GYN, Pediatic, Unlogy, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Feta/Obsterios, Cardiac).
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6) Summary of Technological Characterisitics – New Device compared to Predicates
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| Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------|
| Consists of two parts: the system
console and the transducer. The
system console contains the user
interface, a display, system
electronics and optional
peripherals (printers, etc...).
Includes physical knobs and
buttons of the main control panel
and the user interface which
consists of a Touch Panel, to
access additional less-frequently-
used controls, and the
Alphanumeric Keyboard to enter
patient data and other text. | Identical | Identical | Identical | Identical | |
| SWE Dynamic
Range | --- | Adjustable range capability
and numeric display with
scale | Adjustable
range
capability and
numeric
display with
scale | Identical to
K132274 and
K142100 | |
| Clinical
Applications | Abdominal,
Small Organs*
Musculoskeletal
Superficial Musculoskeletal
Fetal
GYN
Cardiac | Identical
Identical
Identical
Identical
Identical
Identical
--- | Identical
Identical
Identical
Identical
Identical
--- | Identical
Identical
Identical
Identical
Identical
Identical
Identical | |
| | Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device |
| | Adult and neonatal cephalic | Identical | Identical | Identical | Identical |
| | Pediatric | Identical | Identical | Identical | Identical |
| | Urology | Identical | Identical | Identical | Identical |
| | Vascular | Identical | Identical | Identical | Identical |
| | Peripheral Vascular | Identical | Identical | Identical | Identical |
| | Intra-operative | Identical | Identical | Identical | Identical |
| | --- | Laparoscopic | --- | --- | --- |
| | Trans-rectal | --- | Identical | Identical | Identical |
| | Trans-vaginal | Identical | Identical | Identical | Identical |
| Imaging Modes | | | | | |
| | B-mode (Harmonic/Fundamental) | Identical | Identical | Identical | Identical |
| | M-mode, | Identical | Identical | --- | Identical |
| | PW, | Identical | Identical | Identical | Identical |
| Conventional | CW (continuous Wave), | Identical | --- | --- | --- |
| | Color Doppler, | Identical | Identical | Identical | Identical |
| | Amplitude Doppler (CPI) | Identical | Identical | Identical | Identical |
| | Microvascular SMI | --- | --- | --- | Identical (called
Angio PL.U.S) |
| Other | | | | | |
| | Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device |
| | Spatial Compounding, Panoramic,
Contrast | Identical | Identical | Identical | Identical |
| | | Identical | --- | --- | Identical |
| | --- | Elastography | Identical | Identical | Identical |
| | B-mode+Color, | Identical, | Identical | Identical | Identical |
| | B-mode+Color+ PW | Identical | Identical | Identical | Identical |
| Combination | B-mode +PW | Identical | Identical | Identical | Identical |
| | | Identical | --- | --- | Identical |
| | --- | --- | B-mode+Elastography | Identical | Identical |
| Design | | | | | |
| Cart | Mobile cart-based product with
control panel and monitor | Identical | Identical | Identical | Identical |
| Controls | Typical ultrasound imaging
controls including power output,
gain, depth, focus, freeze, PRF,
mode select | Identical | Identical | Identical | Identical |
| | | | | | |
| Transducers | | | | | |
| | Linear Array | Identical | Identical | Identical | Identical |
| | Curved Array | Identical | Identical | Identical | Identical |
| | Phased Array | Identical | Identical | Identical | Identical |
| Transducer
types | --- | Laparoscopic probe | --- | --- | --- |
| | Motorized Linear Probe | Identical | Identical | Identical | Identical |
| | Microconvex probe | Identical | Identical | Identical | Identical |
| | | | | | |
| Biopsy guide | Yes | Yes | Yes | Yes | Yes |
| | Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device |
| Track | Track 3 (Acoustic Output Display) | Identical | Identical | Identical | Identical |
| Patient Contact
Materials | Yes, per ISO-10993-1 | Identical | Identical | Identical | Identical |
| Acoustic Output
within FDA
guidelines | Yes, as per NEMA UD-3 | Identical | Identical | Identical | Identical |
| Image Review | Yes | Identical | Identical | Identical | Identical |
| Measurement
Package | Yes | Identical | Identical | Identical | Identical |
| Calculation
Package | Yes | Identical | Identical | Identical | Identical |
| Report | Yes | Identical | Identical | Identical | Identical |
| General Safety | Conforms to IEC 60601-1, IEC
60601-1-2, IEC 60601-2-37 | Identical | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR Part 801 | Identical | Identical | Identical | Identical |
| General
Description | Consists of two parts: the system
console and the transducer. The
system console contains the user
interface, a display, system
electronics and optional
peripherals (printers, etc...). | Identical | Identical | Identical | Identical |
| General
Description
SWE Dynamic
Range | Includes physical knobs and
buttons of the main control panel
and the user interface which
consists of a Touch Panel, to
access additional less-frequently-
used controls, and the
Alphanumeric Keyboard to enter | Identical | Identical | Identical | Identical to
K142100 and
K132274 |
| Toshiba | Esaote | SuperSonic Imagine | SuperSonic
Imagine | New device | |
| patient data and other text. | | | | | |
| --- | --- | --- | Adjustable
range
capability and
numeric
display with
scale | Identical to
K132274 | |
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Note:
Note:
*: Breast, Thyroid, Testicle, etc
**: --- means not applicable
:. --- means not applicable
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7) A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
| Reference Standard | Tests Performed |
|---|---|
| IEC 60601-1 3.1 Edition | All applicable electrical, basic safety and essential performance tests. |
| IEC 60601-1-2 3rd Edition | All applicable testing pertaining to electromagnetic compatibility. |
| IEC 60601-2-37 2nd Edition | All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. |
| NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstrate compliance with the "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment". |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment". |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category. |
Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.
In addition to the referenced standards testing, performance tests were conducted with respect to new transducers (XC6-1, SEV12-3 and SL18-5).
The above testing confirmed that the Aixplorer® System performs according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® System to the predicate device(s).
8) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Clinical data is not required as the Aixplorer® System uses the same technology and principles as predicate devices.
9) Conclusion
The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2003) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during manufacturing process to ensure compliance with these standards. Consequently, according tests performed, the opinion of SuperSonic Imagine is the submission device is as safe and effective as the predicate devices cited in item 3.