← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K191007
# Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (K191007)
_Supersonic Imagine · IYN · Oct 25, 2019 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K191007
## Device Facts
- **Applicant:** Supersonic Imagine
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Oct 25, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
The SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH 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-CYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH 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 liver and the spleen, Measurements of brightness ratio between liver and kidney, Visualization of abdominal vascularization, microvascularization and perfusion, Quantification of abdominal vascularization and perfusion. The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
## Device Story
Cart-based ultrasound diagnostic system; utilizes various linear, curved, micro-convex, and phased array transducers. Inputs: ultrasound signals from human body. Processing: scan converter transforms signals into images displayed on LCD monitor. Features: B-Mode, M-mode, Color Flow, Pulsed/Continuous Wave Doppler, 3D imaging, CEUS, ShearWave™ elastography, and Strain elastography. Operator: physician or trained clinician. Output: real-time images, measurements, and reports. Clinical use: aids in anatomical structure visualization, vascular/microvascular perfusion quantification, and liver disease management (stiffness/viscosity/attenuation measurements). Benefits: non-invasive diagnostic imaging and quantitative tissue analysis.
## Clinical Evidence
Bench testing only. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasound safety (IEC 60601-2-37), acoustic output (NEMA UD-2, UD-3), and biocompatibility (ISO 10993-1). Engineering comparison of Strain Elastography against Mindray Resona 7 confirmed quantitative and qualitative equivalence.
## Technological Characteristics
Cart-based system with LCD monitor and control panel. Transducers: linear, curved, micro-convex, motorized linear, phased array. Connectivity: digital memory, external printer. Software-controlled. Biocompatible patient-contact materials (ISO 10993-1). Acoustic output complies with NEMA UD-3. Safety standards: IEC 60601-1, 60601-1-2, 60601-2-37.
## Regulatory 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® MACH range Ultrasound Imaging System ([K180572](/device/K180572.md))
- Aplio i900, i800, i700 V2 ([K173090](/device/K173090.md))
- Resona 7 ([K171233](/device/K171233.md))
## Submission Summary (Full Text)
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October 25, 2019
Supersonic Imagine % Jacques Souquet Chief Innovation Officer Les Jardins de la Duranne - Bat E&F 510 rue René Descartes 13857 Aix-en-Provence Cedex FRANCE
Re: K191007
Trade/Device Name: AIXPLORER® MACH 30, AIXPLORER® MACH 20, Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 7, 2019 Received: October 10, 2019
Dear Jacques 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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)
#### K191007
Device Name
AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems
Indications for Use (Describe)
The SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH 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-CYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH 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 liver and the spleen,
- Measurements of brightness ratio between liver and kidney,
- Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
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):
Device Name: AIXPLORER® MACH 30 (SSIP95030) and AIXPLORER® MACH 20 (SSIP95020) Ultrasound Diagnostic Systems
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| | Clinical Application | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|------------------|----------------------------|------------------------------------------------------------------|
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined (Specify) | Other* (Specify) |
| | Ophthalmic | P | P | | | P | P : 1, 3, 4, 11 | P : 5, 6, 10 |
| Fetal Imaging &
Other | Fetal | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11, 13,
14, 15, 16 - N: 21, 22 |
| | Abdominal (including urolology): Liver,
Kidney, Spleen... | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11, 13,
14, 15, 16 - N: 21, 22 |
| | Intra-operative (Specify) vascular,
abdominal, small organs | P | P | | | P | P : 1, 3, 4 | P: 5, 6, 8, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11, 13, 15,
16 - N: 14, 18, 19, 21, 20 |
| | Small Organ (Breast, Thyroid,
Testicle, Prostate, penis, etc...) | P | P | | | P | P : 1, 2, 3, 4,12 | P : 5, 6, 7, 8, 9, 10, 14, 15 -
N : 18, 19, 20, 21 |
| | 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, 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, 15 -
N : 19, 20 |
| | Musculo-skeletal (Superficial) | P | P | | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15 -
N : 19, 20 |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11, 14 |
| | Pelvic | P | P | P | | P | P : 1, 2, 3, 4 | P: 5, 6, 7, 8, 11, 14 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P : 1, 3, 4, 11, 17,
18 | P: 5 |
| | 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, 10, 15 |
| | Other (Specify) | P | | P | | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 |
| 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 (including urolology): Liver,
Kidney, Spleen... | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13,14, 15,
16 – N: 21,22 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 15, 16 –
N: 14, 21, 22 |
| | Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...) | P | P | P | P | P | P: 1, 2, 3, 4,
12 | P: 5, 6, 7, 8, 9, 14, 15 – N:
20, 21, 22 |
| | Neonatal Cephalic | P | P | P | P | P | 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) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14,15 – N:
20 |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15 - N:
20 |
| | 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 | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
| | Other (Specify) | P | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
| | N = new indication; P = Previously cleared by FDA (K180572) | | | | | | | |
| 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 | | 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
17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow | | | | | | |
| 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 | P: 1, 3, 4, 11 | P: 5, 6 |
| Other | Abdominal (including urolology), Liver,
Kidney, Spleen. | P | P | P | | P | P: 1, 2, 3, 4,
11 | P: 5, 6, 7, 8, 9, 13,14, 16 -
N: 21, 22 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 13,16 -
N: 9, 14, 21, 22 |
| | 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) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14 - N: 11 |
| | Pelvic | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14 - N: 11 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric |…
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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K191007](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K191007)
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