AIXPLORER
Device Facts
| Record ID | K142100 |
|---|---|
| Device Name | AIXPLORER |
| Applicant | Supersonic Imagine |
| Product Code | IYN · Radiology |
| Decision Date | Nov 20, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body. 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 and Neonatal/Adult Cephalic. 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, Neonata/Adult Cephalic, Fetal/Obstetrics).
Device Story
Cart-based ultrasound system; performs non-invasive diagnostic imaging. Inputs: acoustic signals via various transducers (linear, curved, micro-convex, motorized linear, phased array). Processing: scan converter transforms signals into images displayed on LCD monitor. Features: B-mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, and ShearWave™ Elastography. Used in clinical settings by healthcare professionals. Output: real-time images, anatomical measurements, and diagnostic reports. Benefits: enables non-invasive visualization and quantification of tissue structures and fluid flow; supports clinical decision-making via standard ultrasound modalities.
Clinical Evidence
No clinical data provided. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD-2, UD-3), and biocompatibility (ISO 10993-1).
Technological Characteristics
Cart-based ultrasound system; LCD monitor; adjustable control panel with touchscreen. Transducers: linear, curved, micro-convex, motorized linear, phased array. Imaging modes: B-mode, M-mode, Color Flow, PWD, Harmonic, Amplitude Doppler, 3D, ShearWave™ Elastography. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3. Biocompatibility: ISO 10993-1. Connectivity: digital memory/external device export.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring abdominal, small organ, musculoskeletal, superficial musculoskeletal, vascular, peripheral vascular, intraoperative, OB-GYN, pelvic, pediatric, urological, trans-rectal, trans-vaginal, and neonatal/adult cephalic examinations.
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 (K132171)
- AIXPLORER® Ultrasound Imaging System (K132274)
- Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786)
- Philips iU22 Ultrasound System (K093563)
Related Devices
- K121329 — AIXPLORER · Supersonic Imagine · Aug 24, 2012
- K171105 — AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems · Supersonic Imagine · Jul 11, 2017
- K102041 — AIXPLORER · Supersonic Imagine · Oct 13, 2010
- 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
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
SuperSonic Imagine % Ms. Aurelie Gruener Senior Regulatory Affairs Manager Les Jardins de la Duranne 510, rue Rene Descartes - Bat. E & F 13 857 Aix-en-Provence FRANCE
Re: K142100 Trade/Device Name: Aixplorer Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 28, 2014 Received: November 5, 2014
Dear Ms. Gruener:
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.
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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,
Robert A. Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K142100
Device Name AIXPLORER® Ultrasound System
The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications:
Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Neonatal/ Adult Cephalic, Fetal/Obstetrics).
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)
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510(k) number (if known): K142100
Device Name: AIXPLORER® Ultrasound System
Intended Use: Diagnostic ultrasound imaging or 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 | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P, 1, 3, 4, 11 | P, 5, 6 |
| | Abdominal (including urolology) | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 |
| | Intra-operative (Specify)<br>vascular, abdominal, small<br>organs | N | N | N | | N | N 1, 3, 4 | N 5, 6, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 |
| | Small Organ (Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 |
| | Neonatal Cephalic | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 |
| | Adult Cephalic | N | N | N | | N | N 1, 3, 4 | N 5, 6 |
| | 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 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 |
| | Pelvic | P | P | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 |
| | 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, 10, 9 |
| | Other (Specify) | P | P | P | | P | P. 1. 3. 4 | P. 5. 6. 8. 9 |
N = new indication; P = previously cleared by FDA (K121329)
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
ing
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)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
AND/OR
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510(k) Number (if known): K142100
Device Name: SL15-4 transducer (1D Linear Array Transducer)
Intended Use: Diagnostic ultrasound imaging or 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 | 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,<br>Thyroid, Testicle, Prostate, Penis) | 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<br>Vessel | Peripheral vessel | P | P | P | P | | P 1, 3, 4 | P 5, 6, 8, 9 |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA (K121329)
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
4: Combined modes include
5: Harmonic Imaging
5: Harmonic Imaging 6: Spatial Compounding
. Spatial Compounding
Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
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): K142100
Device Name: SC6-1 transducer (curved array transducer)
Intended Use: Diagnostic ultrasound imaging or 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 | N | N | N | | N | N, 1, 3, 4, 11 | N, 5, 6 |
| | Abdominal (including urolology) | 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 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<br>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 (K121329)
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
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging 10: 3D Imaging
0. 3D Imaging
1. Combined modes include: D
11: Combined modes include: B+ M modes
Over-The-Counter Use (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): K142100
Device Name: SE12-3 transducer (endocavitary transducer)
Intended Use: Diagnostic ultrasound imaging or 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 & | Fetal | | N | N | N | N | N | N, 1, 3, 4, 11 | N, 5, 6 |
| Other | Abdominal | | | | | | | | |
| | 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 1, 2, 3, 4 | P 5, 6, 7, 8 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | 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 | | | | | | | | |
| Vessel | Other (Specify) | | P | | P | | P | P 1, 3, 4 | P 5, 6, 8 |
N = new indication; P = previously cleared by FDA (K121329)
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
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies 9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{7}------------------------------------------------
510(k) Number (if known): K142100
Device Name: SLV16-5 transducer (motorized linear transducer)
Intended Use: Diagnostic ultrasound imaging or 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 | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10, 9 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10, 9 |
| | Small Organ (for example Breast,<br>Thyroid, Testicle, Prostate, penis,<br>etc...) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10, 9 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10, 9 |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 10, 9 |
| | 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 | P 1, 3, 4 | P 5, 6, 8, 10, 9 |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA (K121329)
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
Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
Over-The-Counter Use (21 CFR 807 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
{8}------------------------------------------------
510(k) Number (if known): K142100
Device Name: SL10-2 transducer (linear transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------------------------------------------|-------------------|--|------------|--|------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | в | | M PWD CWD | | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging Fetal | | | | | | | | |
| & Other | Abdominal | 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, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc ) | P | | D | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 |
| | 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 |
| | Musculo-skeletal (Superficial) | 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 | 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 (K121329)
Additional Comments:
1: Combined modes include: B+ Color Flow
X
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
(Part 21 CFR 801 Subpart D)
Prescription Use
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
11: Combined modes include: B+ M modes
7: ShearWave™ Elastography
9: Panoramic Imaging
10: 3D Imaging
8: Imaging Guidance for Biopsies
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
510(k) Number (if known): K142100
Device Name: SMC12-3 transducer (micro-curved transducer)
Intended Use: Diagnostic ultrasound imaging or 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<br>Abdominal | 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, 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, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 |
| | 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 |
| | Musculo-skeletal (Superficial) | 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<br>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 (K121329)
Additional Comments:
1: Combined modes include: B+ Color Flow
X
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
(Part 21 CFR 801 Subpart D)
Prescription Use
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
11: Combined modes include: B+ M modes
7: ShearWave™ Elastography
9: Panoramic Imaging
10: 3D Imaging
8: Imaging Guidance for Biopsies
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
510(k) Number (if known): K142100
Device Name: XP5-1 transducer (Phased Array transducer)
Intended Use: Diagnostic ultrasound imaging or 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 | N | N | N | N | N | N 1, 3, 4 | N 5, 6 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | N | N | N | N | N | N 1, 3, 4 | N 5, 6 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N 1, 3, 4 | N 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 | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6 |
| | Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6 |
N = new indication; P = previously cleared by FDA (K121329)
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
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging 10: 3D Imaging
11: Combined modes include: B+ M modes
11. Combined modes include: B+ M modes
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): K142100
Device Name: SLH20-6 transducer (linear transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General<br>(Track 1<br>Only) | Clinical Application<br>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 | | | | | | | |
| | Intra-operative (Specify) Vascular,<br>abdominal, small organs | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Intravascular | | | | | | | |
| | GYN | | | | | | | |
| | Pelvic | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
| | Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 9 |
N = new indication; P = previously cleared by FDA (K121329)
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
10: 3D Imaging
11: Combined modes include: B+ M modes
7: ShearWave™ Elastography
9: Panoramic Imaging
8: Imaging Guidance for Biopsies
X Prescription Use (Part 21 CFR 801 Subpart D)
b)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
{12}------------------------------------------------
### 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.
#### 1) 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. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: +1(425) 686 6380
Corresponding Official:
Jacques Souquet Chief Executive Officer Telephone: +33 442 99 24 35
Date: 2014/07/25
#### 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: Aixplorer®
Classification:
Regulatory Class: II
| Classification Name: | 21 CFR Section | Product Code |
|------------------------------------------|----------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
#### 3) Substantially Equivalent/Predicate Devices
AIXPLORER® Ultrasound Imaging System (K132171), cleared on 09/24/2013 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010
{13}------------------------------------------------
### 4) Description of Device
The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, 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 functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
### 5) Intended Use
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.
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 and Neonatal/Adult Cephalic.
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, Neonata/Adult Cephalic, Fetal/Obstetrics).
| | Philips<br>iu22 (predicate) | Siemens Acuson<br>S2000TM<br>(predicate) | SuperSonic<br>Imagine<br>AIXPLORER®<br>(predicate<br>K132171) | SuperSonic<br>Imagine<br>AIXPLORER®<br>(predicate<br>K132274) | SuperSonic<br>Imagine<br>AIXPLORER®<br>(new device) |
|------------------------------------------------|---------------------------------------------------|------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|
| | --** | General Radiology | --** | --** | --** |
| | Abdominal,<br>Small Organs* | Identical | Identical | Identical | Identical |
| | Musculoskeletal | Identical | Identical | Identical | Identical |
| | | Superficial<br>Musculoskeletal | Identical | Identical | Identical |
| Clinical<br>Applications | Fetal | Identical | Identical | --- | Identical |
| | --- | Transcranial | --- | --- | --- |
| | --- | OB | Identical | --- | Identical |
| | | GYN | Identical | Identical | Identical |
| | Cardiac | Identical | --- | --- | --- |
| | --- | Pelvic | Identical | Identical | Identical |
| | Adult and neonatal<br>cephalic | Identical | Identical (for<br>neonatal cephalic) | Identical (for<br>neonatal cephalic) | Identical |
| | Pediatric | Identical | Identical | Identical | Identical |
|…
