Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
Device Facts
| Record ID | K173021 |
|---|---|
| Device Name | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems |
| Applicant | Supersonic Imagine |
| Product Code | IYN · Radiology |
| Decision Date | Jan 9, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems 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 AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion. The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.
Device Story
Cart-based ultrasound system; uses various transducers (linear, curved, micro-convex, phased array) to acquire pulse-echo ultrasound data. System transforms raw acoustic signals into diagnostic images via scan converter; displays on LCD monitor. Features include B-mode, M-mode, Color Flow, Pulsed Wave Doppler, 3D imaging, CEUS, and ShearWave™ elastography. Operated by clinicians in clinical settings. Provides quantitative measurements of shear wave speed, tissue stiffness, and liver/kidney brightness ratios; visualizes/quantifies abdominal vascularization and perfusion. Output aids clinical management of adult liver disease. System controls (gain, depth) allow real-time adjustment per ALARA principles.
Clinical Evidence
Clinical evaluation performed via literature review to support substantial equivalence and expanded indications for use. No prospective clinical trial data provided in this summary.
Technological Characteristics
Mobile cart-based ultrasound system; includes console, display, and various transducers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1. Software-controlled; supports multiple imaging modes (B-mode, M-mode, Doppler, Elastography).
Indications for Use
Indicated for adult patients with liver disease for imaging and measurement of anatomical structures (abdominal, small organs, musculoskeletal, vascular, intraoperative, OB-GYN, pelvic, pediatric, urology, trans-rectal, trans-vaginal, cephalic, cardiac).
Regulatory Classification
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.
Predicate Devices
- AIXPLORER® Ultrasound Imaging System (K171105)
- GE LOGIC S8 including the FibroScan module (K170445)
- FibroScan (K160524)
Related Devices
- K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 · Supersonic Imagine · May 29, 2018
- K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems · Supersonic Imagine · Oct 25, 2019
- K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems · Supersonic Imagine · Dec 29, 2020
- K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 · Supersonic Imagine · Oct 28, 2022
- K203645 — Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 · Supersonic Imagine · Jun 29, 2021
Submission Summary (Full Text)
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January 9, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SuperSonic Imagine, S.A. % Mr. Laurence Hermitte Quality & Regulatory Affairs Director Les Jardins de la Duranne - Bât. E&F 510. rue René Descartes 13857 Aix-en-Provence Cedex FRANCE
## Re: K173021
Trade/Device Name: AIXPLORER® & AIXPLORER® Ultrasound Diagnostic Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 30, 2017 Received: December 7, 2017
Dear Mr. Hermitte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. 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
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## Indications for Use
510(k) Number (if known) K173021
#### Device Name
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems
Indications for Use (Describe)
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems 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 AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs,
Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |
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510(k) number (if known):
Device Name: ÀIXPLORER® Ultrasound Diagnostic System
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | | | | | | | |
|---------------------------|--------------------------------------------------------------------|---|---|------------|--|------------------|--------------------|------------------------------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | | M PWD CWD | | Color<br>Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & | Fetal | P | P | P | | P | P, 1, 3, 4, 11 | P, 5, 6, 10 |
| Other | Abdominal (including urolology): Liver,<br>Kidney, Spleen | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10, 11,13,14 -<br>N 16 |
| | Intra-operative (Specify) vascular,<br>abdominal, small organs | P | | P | | P | P, 1, 3, 4 | P, 5, 6, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 - N 16 |
| | Small Organ (Breast, Thyroid,<br>Testicle, Prostate, penis, etc ) | P | | P | | P | P, 1, 2, 3, 4,12 | P, 5, 6, 7, 8, 9, 10, 14 |
| | Neonatal Cephalic | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 |
| | Adult Cephalic | P | | P | | P | P, 1, 3, 4 | P, 5, 6 |
| | Trans-rectal | 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, 10, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10, 14 |
| | Musculo-skeletal (Superficial) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10, 14 |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 |
| | Pelvic | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P 1, 3, 4, 11 | P, 5 |
| | 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, 10 |
| Vessel | Other (Specify) | P | | P | | P | P, 1, 3, 4 | P, 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K171105)
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
- 8: Imaging Guidance for Biopsies
9: Panoramic Imaging
Prescription Use _ X (Part 21 CFR 801 Subpart D) 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow +
Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S
16: Brightness ratio
Over-The-Counter Use _ (21 CFR 807 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
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510(k) Number (if known): Device Name: SL10-2 transducer (linear transducer, SSIP92085) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | P | | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9,<br>13,14, 15 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 15, N<br>16 |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | | P | P | P | P, 1, 2, 3, 4,<br>12 | P, 5, 6, 7, 8, 9, 14,<br>15 |
| | 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, 14,<br>15 |
| | Musculo-skeletal (Superficial) | P | | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 14,<br>15 |
| | Intravascular | | | | | | | |
| | GYN | | | | | | | |
| | Pelvic | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9, 15 |
| | Other (Specify) | P | | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9, 15 |
N = new indication; P = previously cleared by FDA (K171105)
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
- 8: Imaging Guidance for Biopsies
Imaging Guidance for Biopsies
Elastography
10: 3D Imaging
13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)
11: Combined modes include: B+ M modes
15: Needle PL.U.S
9: Panoramic Imaging
- 16: Brightness ratio
X Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
12: Combined modes include: B Mode + Color flow + Shearwave™
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
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510(k) Number (if known):
Device Name: XC6-1 transducer (curved array transducer, SSIP92167)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P, 1, 3, 4, 11 | P 5, 6 |
| | Abdominal (including urolology), Liver,<br>Kidney, Spleen. | P | P | P | | P | P1, 2, 3, 4, 11 | P 5, 6, 7, 8, 9,<br>13,14, N16 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 13,<br>N16 |
| | Small Organ (Breast, Thyroid, Testicle,<br>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) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8,14 |
| | Pelvic | P | P | P | | P | P1, 2, 3, 4 | P 5, 6, 7, 8, 14 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | P | | P | P1, 3, 4 | P 5, 6, 8 |
| | Other (Specify) | P | | P | | P | P 1, 3, 4 | P 5, 6, 8 |
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
8: Imaging Guidance for Biopsies
9: Panoramic Imaging 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™
Elastography 13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
16: Brightness ratio
Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k) Number (if known):
Device Name: SL15-4 transducer (1D Linear Array Transducer, SSIP92002)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | |
|---------------------------|-------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|--------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Fetal | Fetal | | | | | | | |
| Other | Abdominal (including urolology):<br>Liver, Kidney, Spleen... | P | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 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,<br>Thyroid, Testicle, Prostate, Penis) | P | P | P | | P | P 1, 2, 3, 4, 12 | P 5, 6, 7, 8, 9, 14 |
| | 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, 14 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P 1, 2, 3, 4 | P 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 | P | P | P | | P | P 1, 3, 4 | P 5, 6, 8, 9 |
| Vessel | Other (Specify) | P | P | P | | P | P 1, 3, 4 | P 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K171105)
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
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
9: Panoramic Imaging
11: Combined modes include: B+ M modes
13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)
10: 3D Imaging
Elastography
15: Needle PL.U.S.
Over-The-Counter Use (21 CFR 807 Subpart C)
12: Combined modes include: B Mode + Color flow + Shearwave™
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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510(k) Number (if known):
Device Name: SC6-1 transducer (curved array transducer, SSIP92030)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|--------------------|--|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging & | Fetal | P | P | P | | P | P, 1, 3, 4, 11 | P, 5, 6 | | |
| Other | Abdominal (including urolology), Liver,<br>Kidney, Spleen | P | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9,11 | | |
| | 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,<br>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 | Peripheral vessel | P | | P | | P | P 1, 3, 4 | P 5, 6, 8, 9 | | |
| Vessel | Other (Specify) | P | | P | | P | P 1, 3, 4 | P 5, 6, 8, 9 | | |
N = new indication; P = previously cleared by FDA (K171105)
Additional Comments:
1: Combined modes include: B+ Color Flow
1: Sombined 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
TM Elastography
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
13: C
14: A
for Biopsies
ΔΤ
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 + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
510(k) Number (if known):
Device Name: SE12-3 transducer (endocavitary transducer, SSIP92068 & SSIP93068)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------------------------------------|--|-------------------|-----|-----|------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | B M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | P P | P | | P | P 1, 3, 4, 11 | P 5, 6 | |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | 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,<br>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,<br>11 | |
| | Pelvic | | P P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8,<br>11 | |
| | Other (Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | P | P | | P | P 1, 3, 4 | P 5, 6, 8 | |
N = new indication; P = previously cleared by FDA (K171105)
| | | 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
9: Panoramic Imaging
0: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
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
{9}------------------------------------------------
510(k) Number (if known):
Device Name: SLV16-5 transducer (motorized linear transducer, SSIP90055 & SSIP93055)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal (including urolology):<br>Liver, Kidney, Spleen... | 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 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 |
| | Small Organ (for example Breast,<br>Thyroid, Testicle, Prostate, penis,<br>etc...) | 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 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 |
| | Musculo-skeletal (Superficial) | 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<br>Vessel | Peripheral vessel | P | | P | P | | P 1, 3, 4 | P 5, 6, 8, 9, 10 |
| | Other (Specify) | | | | | | | |
| | N = new indication; P = previously cleared by FDA (K171105) | | | | | | | |
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
8: Imaging Guidance for Biopsies
- 9: Panoramic Imaging 10: 3D Imaqinq
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
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)
{10}------------------------------------------------
510(k) Number (if known):
Device Name: SMC12-3 transducer (micro-curved transducer, SSIP92097)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | 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,<br>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 | P | P | P | | P | P 1,3,4,5,11 | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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 (K171105)
Additional Comments:
1: Combined modes include: B+ Color Flow
1: Sombined 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
7: ShearWave™ Elastography
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 + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
510(k) Number (if known):
Device Name: XP5-1 transducer (Phased Array transducer, SSIP92161)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human
body as follows: Clinical Application Mode of Operation M PWD CWD Specific B Color Combined General Other* (Specify) (Track 1 Only) (Tracks 1 & 3) Doppler (Specify) Ophthalmic Ophthalmic Fetal Imaging Fetal & Other Abdominal (including urolology): Liver, P P P P 1, 3, 4 P 5, 6 Kidney, Spleen ... Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ (for example Breast, Thyroid, P P P P 1, 3, 4 P 5, 6 Testicle, Prostate, penis, etc ... ) Neonatal Cephalic Adult Cephalic 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 P P P P P1, 3, 4, 5, 11 Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel P P P P 1. 3. 4 P 5.6 P P P Vessel Other (Specify) P 1, 3, 4 P 5, 6
N = new indication; P = previously cleared by FDA (K171105)
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
8: Imaging Guidance for Biopsies
9: Panoramic Imaging 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
AND/OR
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)
{12}------------------------------------------------
510(k) Number (if known):
Device Name: SLH20-6 transducer (linear transducer, SSIP92164 & SSIP93164)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | | | | Mode of Operation | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----|------------------------------------------------|-----------------------|----------------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | | | | | | | |
| | Intra-operative (Specify) Vascular,<br>abdominal, small organs | P | P | P | | P | P 1, 3, 4 | P 5, 6, 9, 15 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
|…
