Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems by Supersonic Imagine

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.

Device Description

The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems 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 (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-Color Flow Imaging, CPI-Color Power Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaye™ elastography and Strain Elastography.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence for the AIXPLORER® MACH 30 and AIXPLORER® MACH 20 Ultrasound Diagnostic Systems to predicate devices. It doesn't explicitly state numerical acceptance criteria in the format of a performance table like sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the new device performs at least as safely and effectively as the predicate devices and complies with relevant regulatory standards.

The device performance is demonstrated through compliance with a set of international and FDA-recognized standards and through a comparative engineering test.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance
Safety	Compliance with electrical, basic safety, essential performance, electromagnetic compatibility, and acoustic output standards. Biocompatibility of patient contact materials.	"All applicable electrical, basic safety and essential performance tests," "All applicable testing pertaining to electromagnetic compatibility," "All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment" (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37). "Yes, per ISO 10993-1" for patient contact materials. "Yes, as per NEMA UD-3" for acoustic output within FDA guidelines.
Effectiveness	Performance according to intended use for various clinical applications and imaging modes. Substantial equivalence in imaging modes and measurements, including new indications (Vi PLUS, Att PLUS, SSp PLUS, Strain Elastography).	"The Aixplorer® MACH Systems perform according to the stated intended use." "Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side." The device tables indicate "New" for Vi PLUS, Att PLUS, and SSp PLUS modalities, implying their successful implementation and functionality.
Labeling	Conformance to 21 CFR Part 801.	"Conforms to 21 CFR Part 801."
Quality System	Compliance with 21 CFR Part 820 and ISO 13485 (2016).	"The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention "test set" in the context of clinical images or patient data for evaluating AI performance. The studies described are primarily non-clinical engineering and regulatory compliance tests.

For the Strain Elastography engineering test, a specific sample size of cases or patients is not provided. It mentions a comparison "between Aixplorer® MACH and Mindray Resona 7," implying a technical evaluation rather than a clinical study with a patient cohort.

Data Provenance: Not applicable in the context of detailed clinical study data for AI performance. The regulatory compliance testing refers to international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that the primary evidence cited is non-clinical engineering tests and adherence to standards, there is no mention of "experts" establishing ground truth for a clinical test set in the conventional sense of human readers. The "ground truth" for the engineering tests would be derived from the specifications and established performance of the predicate device and the physical principles verified by the tests themselves.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with human readers and adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The submission focuses on establishing substantial equivalence to predicate devices for the ultrasound system itself and new indications, rather than the performance of AI-assisted interpretation by human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No standalone algorithm-only performance study is explicitly mentioned. The "AIXPLORER® MACH" systems themselves perform diagnostic ultrasound imaging, and newer functionalities like "Vi PLUS," "Att PLUS," and "SSp PLUS" are described as features of the diagnostic system, not necessarily as standalone AI algorithms for image interpretation or diagnosis. The "engineering test of Strain Elastography" compares the device's technical output to a predicate, not an AI algorithm's diagnostic output.

7. The Type of Ground Truth Used

For the engineering tests and compliance studies, the "ground truth" is based on:

Regulatory Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1. These standards define the acceptable technical and safety performance.
Predicate Device Performance: The performance of the predicate ultrasound systems (AIXPLORER® MACH range sw V1, Aplio i900, i800, i700 V2.0, Resona 7) serves as the benchmark for "equivalence" in aspects like imaging modes and intended use.
Physical Measurements and Quantitative/Qualitative Comparison: For the Strain Elastography test, the ground truth would be the known and verifiable measurements and output of the predicate Mindray Resona 7.

8. The Sample Size for the Training Set

No information about a training set for an AI/algorithm is provided. The document describes a medical device (ultrasound system) that relies on engineering principles and established imaging techniques, not a deep learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/algorithm is mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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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	ColorDoppler	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)
PeripheralVessel	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	ColorDoppler	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)
PeripheralVessel	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 Flow2: Combined modes include: B+ ShearWave™ Elastography3: Combined modes include: B+ Pulsed Wave4: Combined modes include: B+ Pulsed Wave + Color Flow5: Harmonic Imaging6: Spatial Compounding7: ShearWave™ Elastography		12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography13: CEUS (Contrast Enhancement UltraSound)14: Angio PL.U.S (Color Doppler improvement)15: Needle PL.U.S16: Brightness ratio17: Combined mode include: B+ Continuous Wave18: 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	ColorDoppler	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
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

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

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

Prescription Use _ X

(Part 21 CFR 801 Subpart D)

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Diagnostic Ultrasound Indications for Use

510(k) Number (if known):

Device Name: L10-2 transducer (linear transducer, SSIP95103)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

9: Panoramic Imaging

Panoramic Image
3D Image

10: 3D Imaging

11: Combined modes include: B+ M mode

Prescription Use _ X (Part 21 CFR 801 Subpart D) 20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS
22: Att PLUS & SSp PLUS AND/OR

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):

Device Name: C6-1X transducer (curved array transducer, SSIP95101)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

N = new indication; P = Previously cleared by FDA (K180572

2: Combined modes include: B+ ShearWave™ Elastography

4: Combined modes include: B+ Pulsed Wave + Color Flow

Additional Comments:

5: Harmonic Imaging

9: Panoramic Imaging

10: 3D Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

11: Combined modes include: B+ M mode

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

19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS
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)

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510(k) Number (if known):

Device Name: E12-3 transducer (endocavitary transducer, SSIP95102)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P : 1, 3, 4, 11	P : 5, 6
	Abdominal (including urolology): Liver, Kidney,Spleen...
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example 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	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	Trans-vaginal	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Pelvic	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8
	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal (including urolology):Liver, Kidney, Spleen...	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Musculo-skeletal (Superficial)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P		P: 1, 3, 4	P: 5, 6, 8, 9, 10
Vessel	Other (Specify)
	N = new indication; P = Previously cleared by FDA (K180572)
	1: Combined modes include: B+ Color Flow2: Combined modes include: B+ ShearWave™ Elastography3: Combined modes include: B+ Pulsed Wave4: Combined modes include: B+ Pulsed Wave + Color Flow		12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography		13: CEUS (Contrast Enhancement UltraSound)14: Angio PL.U.S (Color Doppler improvement)
	5: Harmonic Imaging6: Spatial Compounding7: ShearWave™ Elastography8: Imaging Guidance for Biopsies		15: Needle PL.U.S16: Brightness ratio17: Combined mode include: B+ Continuous Wave18: Combined mode include: B+ M mode + Color flow
	9: Panoramic Imaging10: 3D Imaging11: Combined modes include: B+ M mode		19: Strain Elastography20: Combined mode: B Mode + Strain + SWE21: Vi PLUS22: Att PLUS & SSp PLUS
Prescription Use	X						AND/OROver-The-Counter Use
	Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Neonatal Cephalic	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P: 1,3,4,11	P: 5, 6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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 (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

Prescription Use

(Part 21 CFR 801 Subpart D)

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 mode

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

{7}------------------------------------------------

510(k) Number (if known):

Device Name: LV16-5 transducer (motorized linear transducer, SSIP95108)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

{8}------------------------------------------------

510(k) Number (if known):

Device Name: MC12-3 transducer (micro-curved transducer, SSIP95106)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

N = new indication; P = Previously cleared by FDA (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

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS
22: Att PLUS & SSp PLUS

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)

{9}------------------------------------------------

510(k) Number (if known):

Device Name: P5-1X transducer (Phased Array transducer, SSIP95107)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P	P	P	P: 1, 3, 4, 11,17	P: 5, 6, 16
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P	P	P	P: 1, 3, 4	P: 5, 6
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P: 1, 3, 4	P: 5, 6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P: 1, 3, 4, 11,17, 18	P: 5, 6
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P: 1, 3, 4, 17	P: 5, 6
	Other (Specify)	P	P	P	P	P	P: 1, 3, 4, 17	P: 5, 6
	N = new indication; P = Previously cleared by FDA (K180572)
	1: Combined modes include: B+ Color Flow

Combined modes include: D+ Color Flow
Combined modes include: B+ ShearWave™ Elastography

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 mode

Use X
(801 Subpart D)

graphy

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

Prescription Use	X
------------------	---

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

{10}------------------------------------------------

510(k) Number (if known):

Device Name: LH20-6 transducer (linear transducer, SSIP95104)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

	Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...
	Intra-operative (Specify) Vascular,abdominal, small organs	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Musculo-skeletal (Superficial)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15
	Other (Specify)	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15

1: Combined modes include: B+ Color Flow

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

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 mode

Prescription Use (Part 21 CFR 801 Subpart D) 17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

15: Needle PL.U.S

16: Brightness ratio

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use

{11}------------------------------------------------

510(k) Number (if known):

Device Name: L18-5 transducer Linear Array Transducer, SSIP95100)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal			P
	Abdominal (including urolology):Liver, Kidney, Spleen...	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P: 1, 2, 3, 4, 12	P: 5, 6, 7, 8, 9, 14 – N: 19,20
	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, 9,14, 15 – N:19, 20
	Musculo-skeletal (Superficial)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9,14, 15 – N:19, 20
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9, 15
	Other (Specify)	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

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

Prescription Use _ X (Part 21 CFR 801 Subpart D) 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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS
22: Att PLUS & SSp PLUS

AND/OR

Over-The-Counter Use

1 Subpart D)

(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) Diagnostic Ultrasound Indications for Use

{12}------------------------------------------------

510(k) Number (if known):

Device Name: C9-2X transducer, curved array transducer (SSIP95105)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
Other	Abdominal (including 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: 21,22
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	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	P: 1, 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	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

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 mode

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

20: Combined mode: B Mode + Strain + SWE

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

(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)

15: Needle PL.U.S

16: Brightness ratio

21: Vi PLUS

19: Strain Elastography

22: Att PLUS & SSp PLUS

{13}------------------------------------------------

510(k) Summary of Safety and Effectiveness K191007

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. Weston North America Telephone: +1(954) 660 3528

Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35

Date: 2019.10.24

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: Ultrasound Diagnostic System with Accessories Proprietary Name: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20

Classification: 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® MACH range Ultrasound Imaging System (K180572), cleared on 05/29/2018 Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 Resona 7 (K171233) cleared on 09/12/2017

{14}------------------------------------------------

4) Description of Device

5) Indication for Use

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-GYN. 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 brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric with liver disease.

{15}------------------------------------------------

	SuperSonic Imagine	Canon MedicalSystem	Mindray medicalInternational	SuperSonic Imagine
	Aixplorer MACHrange sw V1	Aplio i900, i800 andi700 V2.0	Resona 7	AIXPLORER® MACHrange sw V2
	(predicates)	(predicate)
510(k) Number	K180572	K173090	K171233	K191007
ClassificationName	Ultrasonic PulsedDoppler ImagingSystem (892.1550)Ultrasonic Pulsed EchoImaging System(892.1560)Diagnostic UltrasoundTransducer (892.1570)	Identical to K180572	Identical to K180572	Identical to K180572
Class	Class II	Identical	Identical	Identical
Intended Use	Diagnostic ultrasoundimaging, soft tissueelasticity imaging, fluidflow analysis of thehuman body	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody	Diagnostic Ultrasoundimaging or fluid flowanalysis of the humanbody	Identical to K180572
	General purpose,mobile, softwarecontrolled diagnosticultrasound system. Toacquire ultrasound dataand to display the datain various modes ofoperation.	Identical	Identical	Identical
GeneralDescription	Consists of two parts:the system consoleand the transducer.The system consolecontains the userinterface, a display,system electronicsand optionalperipherals (printers,etc...).	Identical	Identical	Identical
ClinicalApplications	Abdominal (liver,kidney, spleen)	Identical	Identical	Identical
	SuperSonic Imagine	Canon MedicalSystem	Mindray medicalInternational	SuperSonic Imagine
	Small organs (*)	Identical	Identical	Identical
	Musculoskeletal	Identical	Identical	Identical
	Fetal	Identical	Identical	Identical
	GYN	Identical	Identical	Identical
	Cardiac (non invasive)	Cardiac	Identical	Identical
	Adult and neonatalcephalic	Identical	Identical	Identical
	Pediatric	Identical	Identical	Identical
	Urology	Identical	Identical	Identical
	Vascular	Identical	Identical	Identical
	Peripheral vascular	Identical	Identical	Identical
	Trans-rectal	Identical	Identical	Identical
	Trans-vaginal	Identical	Identical	Identical
Imaging modes
	B-Mode (Harmonic,Fundamental)	Identical	Identical	Identical
	M-Mode	Identical	Identical	Identical
	PW	Identical	Identical	Identical
Conventional	CW	Identical	Identical	Identical
	Color Doppler	Identical	Identical	Identical
	Amplitude Doppler	Identical	Identical	Identical
	Microvascular (AngioPL.U.S)	---(**)	--	Identical
Other	Spatial compounding,Panoramic	Identical	Identical	Identical
	Contrast	Identical	Identical	Identical
	SuperSonic Imagine	Canon MedicalSystem	Mindray medicalInternational	SuperSonic Imagine
Combination of modes	Identical	Identical	Identical
ShearWaveElastography	Identical	Identical	Identical
Strain Elastography	--	Identical to K191007	Identical to K191007
Design
Cart	Mobile cart basedproduct with controlpanel and monitor	Identical	Identical	Identical
Controls	Typical ultrasoundimaging controls (gain,depth mode select...)	Identical	Identical	Identical
Biopsy guide	Available	Identical	Identical	Identical
Track	Track 3 (AcousticOutput Display)	Identical	Identical	Identical
Patient ContactMaterials	Yes, per ISO 10993-1	Identical	Identical	Identical
Acoustic Outputwithin FDAguidelines	Yes, as per NEMAUD-3	Identical	Identical	Identical
Image Review	Yes	Identical	Identical	Identical
MeasurementPackage	Yes	Identical	Identical	Identical
CalculationPackage	Yes	Identical	Identical	Identical
Report	Yes	Identical	Identical	Identical
General Safety	Conforms toIEC60601-1, 60601-1-2, 60601-2-37	Identical	Identical	Identical
Labeling	Conforms to 21 CFRPart 801	Identical	Identical	Identical

6) Summary of Technological Characterisitics – New Device compared to Predicates

{16}------------------------------------------------

{17}------------------------------------------------

Note:

*: Breast, Thyroid, Testicle, etc
**:--- means not applicable

:: --- means not applicable

{18}------------------------------------------------

	SuperSonicImagine	CanonMedicalSystem	Mindray MedicalInternational	SupersonicImagine
	AixplorerMACH range(sw v1)	Aplio i900;i800 & i700v2.0	Resona 7	AixplorerMACH range(sw v2)
510(k)number	K180572	K173090	K171233	K191007
Vi PLUS	No	Yes, SWD	No	New
Att PLUS	No	Yes, ATI	No	New
SSp PLUS	No	No	Yes, SSC Sound speedcorrection/Compensation	New

1. A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
  Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.

Reference Standard	Tests Performed
IEC 60601-1 Ed.3.1	All applicable electrical, basic safety and essentialperformance tests.
IEC 60601-1-2 Ed.4	All applicable testing pertaining to electromagneticcompatibility.
IEC 60601-2-37 Ed.2.1	All applicable testing pertaining to the particularrequirements for the safety of ultrasonic medicaldiagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstratecompliance with the "Accoustic OutputMeasurement Standard for Diagnostic UltrasoundEquipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstratecompliance with the "Standard For Real TimeDisplay Of Thermal And Mechanical AcousticOutput Indices On Diagnostic UltrasoundEquipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriatedevice category.

The above testing confirmed that the Aixplorer® MACH Systems perform according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s).

Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side.

8) Conclusion

The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.