Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related technologies in the device description or intended use. The focus is on standard ultrasound imaging modes and elastography.

Therapeutic

No
The device is described as an "ultrasound diagnostic system" intended for "imaging and measurement of anatomical structures" and "general purpose pulse echo ultrasound imaging." Its primary function is diagnostic, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is an "ultrasound diagnostic systems". It further details its use for "imaging and measurement of anatomical structures" and notes that its measurements "may be used as an aid to clinical management of adult patients with liver disease," all of which point to a diagnostic purpose. The "Device Description" also refers to it as a system "used to perform noninvasive diagnostic general purpose ultrasound studies."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "cart based ultrasound imaging system" and includes hardware components like transducers, a scan converter, a monitor, and a control panel.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device Description and Intended Use: The description clearly states that the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate systems are ultrasound diagnostic systems used to perform noninvasive diagnostic general purpose ultrasound studies. They use pulse echo ultrasound imaging and other ultrasound-based techniques to visualize and measure anatomical structures and fluid flow within the body.
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is based on sending and receiving ultrasound waves to create images and perform measurements directly on the patient.

Therefore, since the device operates by imaging the body directly rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for:

Measurements of abdominal anatomical structures,
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,
Measurements of brightness ratio between liver and kidney,
Visualization of abdominal vascularization, microvascularization and perfusion,
Quantification of abdominal vascularization and perfusion.

The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing 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 aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in 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 CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Liver, Kidney, Spleen

Indicated Patient Age Range

Adult, Neonatal, Pediatric

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices: IEC 60601-1 3.1 Edition, IEC 60601-1-2 3rd Edition, IEC 60601-2-37 2nd Edition, NEMA UD 2 (Rev. 3), NEMA UD 3 (Rev. 2), ISO 10993-1. The above testing confirmed that the Aixplorer® and Aixplorer® Ultimate 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® and Aixplorer® Ultimate Systems to the predicate device(s).

The subject of this premarket submission required a clinical evaluation by literature route to support substantial equivalence and to widen the indications for use of Aixplorer® Ultimate Ultrasound Diagnostic Systems.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171105, K170445, K160524

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

January 9, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

SuperSonic Imagine, S.A. % Mr. Laurence Hermitte Quality & Regulatory Affairs Director Les Jardins de la Duranne - Bât. E&F 510. rue René Descartes 13857 Aix-en-Provence Cedex FRANCE

Re: K173021

Trade/Device Name: AIXPLORER® & AIXPLORER® Ultrasound Diagnostic Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 30, 2017 Received: December 7, 2017

Dear Mr. Hermitte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K173021

Device Name

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems

Indications for Use (Describe)

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs,

Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion.

The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,

microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.

Type of Use (Select one or both, as applicable)
☑ 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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510(k) number (if known):

Device Name: ÀIXPLORER® Ultrasound Diagnostic System

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

Clinical Application
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B		M PWD CWD		Color
Doppler	Combined (Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal	P	P	P		P	P, 1, 3, 4, 11	P, 5, 6, 10
Other	Abdominal (including urolology): Liver,
Kidney, Spleen	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10, 11,13,14 -
N 16
	Intra-operative (Specify) vascular,
abdominal, small organs	P		P		P	P, 1, 3, 4	P, 5, 6, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10 - N 16
	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
	Neonatal Cephalic	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic	P		P		P	P, 1, 3, 4	P, 5, 6
	Trans-rectal	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8
	Trans-vaginal	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 11
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10, 14
	Musculo-skeletal (Superficial)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10, 14
	Intravascular
	GYN	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 11, 14
	Pelvic	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 11, 14
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P		P	P 1, 3, 4, 11	P, 5
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P		P	P, 1, 3, 4	P, 5, 6, 8, 9, 10
Vessel	Other (Specify)	P		P		P	P, 1, 3, 4	P, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies
9: Panoramic Imaging

Prescription Use _ X (Part 21 CFR 801 Subpart D) 10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow +

Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S
16: Brightness ratio

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

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

AND/OR

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510(k) Number (if known): Device Name: SL10-2 transducer (linear transducer, SSIP92085) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(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, 1, 2, 3, 4	P, 5, 6, 7, 8, 9,
13,14, 15
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 15, N
16
	Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)	P		P	P	P	P, 1, 2, 3, 4,
12	P, 5, 6, 7, 8, 9, 14,
15
	Neonatal Cephalic	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 14,
15
	Musculo-skeletal (Superficial)	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 14,
15
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P		P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9, 15
	Other (Specify)	P		P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9, 15

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies
Imaging Guidance for Biopsies

Elastography

10: 3D Imaging

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

11: Combined modes include: B+ M modes

15: Needle PL.U.S

9: Panoramic Imaging

16: Brightness ratio
X Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

AND/OR

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510(k) Number (if known):

Device Name: XC6-1 transducer (curved array transducer, SSIP92167)

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal	P	P	P		P	P, 1, 3, 4, 11	P 5, 6
	Abdominal (including urolology), Liver,
Kidney, Spleen.	P	P	P		P	P1, 2, 3, 4, 11	P 5, 6, 7, 8, 9,
13,14, N16
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 13,
N16
	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
	Pelvic	P	P	P		P	P1, 2, 3, 4	P 5, 6, 7, 8, 14
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P		P		P	P1, 3, 4	P 5, 6, 8
	Other (Specify)	P		P		P	P 1, 3, 4	P 5, 6, 8

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

9: Panoramic Imaging 10: 3D Imaging

11: Combined modes include: B+ M modes

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

Elastography 13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

16: Brightness ratio

Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) Number (if known):

Device Name: SL15-4 transducer (1D Linear Array Transducer, SSIP92002)

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

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

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

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

9: Panoramic Imaging

11: Combined modes include: B+ M modes

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

10: 3D Imaging

Elastography

15: Needle PL.U.S.

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

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

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

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510(k) Number (if known):

Device Name: SC6-1 transducer (curved array transducer, SSIP92030)

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

Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal	P	P	P		P	P, 1, 3, 4, 11	P, 5, 6
Other	Abdominal (including urolology), Liver,
Kidney, Spleen	P	P	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9,11
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Small Organ (Breast, Thyroid, Testicle,
Prostate, penis, etc )	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Intravascular
	GYN	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Pelvic	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P		P	P 1, 3, 4	P 5, 6, 8, 9
Vessel	Other (Specify)	P		P		P	P 1, 3, 4	P 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Sombined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave
TM Elastography

7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

13: C
14: A

for Biopsies

ΔΤ

Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

AND/OR

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

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

8

510(k) Number (if known):

Device Name: SE12-3 transducer (endocavitary transducer, SSIP92068 & SSIP93068)

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

	Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)		B M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal		P P	P		P	P 1, 3, 4, 11	P 5, 6
	Abdominal (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	P 5, 6, 7, 8,
11
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN		P P	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8,
11
	Pelvic		P P	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8,
11
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)		P	P		P	P 1, 3, 4	P 5, 6, 8

N = new indication; P = previously cleared by FDA (K171105)

		Additional Comments:
--	--	----------------------

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

0: 3D Imaging

11: Combined modes include: B+ M modes

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

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

9

510(k) Number (if known):

Device Name: SLV16-5 transducer (motorized linear transducer, SSIP90055 & SSIP93055)

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

Clinical Application		Mode of Operation
General
(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 1, 2, 3, 4	P 5, 6, 7, 8, 9, 10
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9, 10
	Small Organ (for example Breast,
Thyroid, Testicle, Prostate, penis,
etc...)	P		P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9, 10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9, 10
	Musculo-skeletal (Superficial)	P		P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9, 10
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P		P	P		P 1, 3, 4	P 5, 6, 8, 9, 10
	Other (Specify)
	N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging 10: 3D Imaqinq
11: Combined modes include: B+ M modes

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

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

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

10

510(k) Number (if known):

Device Name: SMC12-3 transducer (micro-curved transducer, SSIP92097)

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

Clinical Application		Mode of Operation
General
(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, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Neonatal Cephalic	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P		P	P 1,3,4,5,11
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P		P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9
	Other (Specify)	P		P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Sombined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave
™
Elastography

7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

Prescription Use __ X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

AND/OR

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

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

11

510(k) Number (if known):

Device Name: XP5-1 transducer (Phased Array transducer, SSIP92161)

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

body as follows: Clinical Application Mode of Operation M PWD CWD Specific B Color Combined General Other* (Specify) (Track 1 Only) (Tracks 1 & 3) Doppler (Specify) Ophthalmic Ophthalmic Fetal Imaging Fetal & Other Abdominal (including urolology): Liver, P P P P 1, 3, 4 P 5, 6 Kidney, Spleen ... Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ (for example Breast, Thyroid, P P P P 1, 3, 4 P 5, 6 Testicle, Prostate, penis, etc ... ) Neonatal Cephalic Adult Cephalic P P P P 1, 3, 4 P 5, 6 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular GYN Pelvic Other (Specify) Cardiac Cardiac Adult P P P P P1, 3, 4, 5, 11 Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel P P P P 1. 3. 4 P 5.6 P P P Vessel Other (Specify) P 1, 3, 4 P 5, 6

N = new indication; P = previously cleared by FDA (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging 10: 3D Imaging

11: Combined modes include: B+ M modes

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

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

12

510(k) Number (if known):

Device Name: SLH20-6 transducer (linear transducer, SSIP92164 & SSIP93164)

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

Clinical Application				Mode of Operation
General
(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...
	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 1, 3, 4	P 5, 6, 9, 2, 7, 15
	Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)	P	P			P	P 1, 3, 4	P 5, 6, 9, 2, 7, 15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P 1, 3, 4	P 5, 6, 9, 2, 7, 15
	Musculo-skeletal (Superficial)	P	P	P		P	P 1, 3, 4	P 5, 6, 9, 2, 7, 15
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P 1, 3, 4	P 5, 6, 9, 15
	Other (Specify)	P	P	P		P	P 1, 3, 4	P 5, 6, 9, 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	P	P	P		P	P, 1, 3, 4, 11	P, 5, 6,
10
	Abdominal (including urology): 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, 10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P		P		P	P 1, 2, 3, 4	P 5, 6,
7, 8, 10
	Trans-vaginal	P	P	P		P	P1, 2, 3, 4, 11	P 5, 6,
7, 8, 10
	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, 10
	Pelvic	P	P	P		P	P 1, 2, 3, 4, 11	P 5, 6,
7, 8, 10
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
N = new indication; P = previously cleared by FDA (K171105)
Additional Comments:
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Prescription Use: X
(Part 21 CFR 801 Subpart D)			9: Panoramic Imaging
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
10: 3D Imaging
11: Combined modes include: B+ M modes
3: Combined modes include: B+ Pulsed Wave
12: Combined modes include: B Mode + Color flow + Shearwave™
4: Combined modes include: B+ Pulsed Wave + Color Flow
Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
AND/OR			Over-The-Counter Use
(21 CFR 807 Subpart C)
Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Fetal
Other	Abdominal (including urolology):
Liver, Kidney, Spleen...	P	P	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	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9, 15
	Small Organ (for example Breast,
Thyroid, Testicle, Prostate, Penis)	P	P	P	P	P	P 1, 2, 3, 4
P 12	P 5, 6, 7, 8, 9, 14,
15
	Neonatal Cephalic	P	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	P 1, 2, 3, 4	P 5, 6, 7, 8, 9,14,
15
	Musculo-skeletal (Superficial)	P	P	P	P	P	P 1, 2, 3, 4	P5, 6, 7, 8, 9,14,
15
	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	P 1, 3, 4	P 5, 6, 8, 9, 15
Vessel	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 (K171105)

Additional Comments:

1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

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

9: Panoramic Imaging
11: Combined modes include: B+ M modes

Combined modes include: B+ M modes
Combined modes include: B Mode + 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)

15: Needle PL.U.S. AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)

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

13

510(k) Number (if known):

Device Name: SEV12-3 transducer (endocavitary transducer, SSIP92189)

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

(Part 21 CFR 801 Subpart D)

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

14

510(k) Number (if known):

Device Name: SL18-5 transducer (1D Linear Array Transducer, SSIP92501)

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 (K171105)

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

Prescription Use _

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

(Part 21 CFR 801 Subpart D)

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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

Elastography

13: CEUS (Contrast Enhancement UltraSound)

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

15: Needle PL.U.S.

AND/OR

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

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

15

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.

Submitter's name, address, telephone number, contact person Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne – Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24

Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: +1(954) 660 3528

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

Date: 2017.09.15

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, if known:
  Common/Usual Name: Ultrasound Diagnostic System with Accessories Proprietary Name: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems

16

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® Ultrasound Imaging System (K171105), cleared on 07/11/2017 GE LOGIC S8 including the FibroScan module (K170445), cleared on 04/11/2017 FibroScan (K160524), cleared on 03/18/2016

4) Description of Device

The SuperSonic Inagine AIXPLORER® & AIXPLORER® Utimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing 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 aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in 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 CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.

5) Indication for Use

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatominal), Small Organs, Musculoskeletal, Superficial Musculoskeleta, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatic, Urology, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Inagine AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for:

Measurements of abdominal anatomical structures,

17

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 shear wave speed and stiffness measurements, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization and perusion may be used as an aid to clinical management of adult patients with liver disease.

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

	SuperSonic Imagine	GE	Echosens	SuperSonic Imagine
	SuperSonic Imagine
AIXPLORER® &
AIXPLORER® Ultimate
(predicates)	GE LOGIC S8 including the
FibroScan module
(predicate)	Fibroscan 530 Compact
(predicate)	SuperSonic Imagine
AIXPLORER® &
AIXPLORER® Ultimate
510(k) Number	K171105	K170445	K160524	Unassigned
Classification
Name	Ultrasonic Pulsed Doppler
Imaging System (892.1550)
Ultrasonic Pulsed Echo Imaging
System (892.1560)
Diagnostic Ultrasound
Transducer (892.1570)	Ultrasonic Pulsed Doppler
Imaging System (892.1550)
Ultrasonic Pulsed Echo
Imaging System (892.1560)
Diagnostic Ultrasound
Transducer (892.1570)	Ultrasonic Pulsed Echo Imaging
System (892.1560)
Diagnostic Ultrasound
Transducer (892.1570)	Identical to K171105 and
K170445
Class	Class II	Identical	ldentical	Identical
Intended Use	Diagnostic ultrasound imaging,
soft tissue elasticity imaging,
fluid flow analysis of the human
body	Diagnostic Ultrasound imaging
or fluid flow analysis of the
human body	Diagnostic Ultrasound imaging
or fluid flow analysis of the
human body	Identical
	SuperSonic Imagine	GE	Echosens	SuperSonic Imagine
General
Description	General purpose, mobile,
software controlled diagnostic
ultrasound system. To acquire
ultrasound data and to display
the data in various modes of
operation.	Identical	Identical	Identical
	Consists of two parts: the
system console and the
transducer. The system console
contains the user interface, a
display, system electronics and
optional peripherals (printers,
etc...).	Identical	Identical	Identical
SWE Dynamic
Range	Adjustable range capability and
numeric display with scale	---	---	Identical to K171105
Clinical
Applications	Abdominal	Identical	Identical	Identical
	Small organs	Identical	---	Identical to K171105 and
K170445
	Musculoskeletal	Identical	---	Identical to K171105 and
K170445
	Fetal	Identical	---	Identical to K171105 and
K170445
	GYN	Identical	---	Identical to K171105 and
K170445
	Cardiac	Identical	---	Identical to K171105 and
K170445
	Adult and neonatal cephalic	Identical	---	Identical to K171105 and
K170445
	SuperSonic Imagine	GE	Echosens	SuperSonic Imagine
	Pediatric	Identical	Identical	Identical
	Urology	Identical	---	Identical to K171105 and
K170445
	Vascular	Identical	---	Identical to K171105 and
K170445
	Peripheral vascular	Identical	---	Identical to K171105 and
K170445
	Intraoperative	Identical	---	Identical to K171105 and
K170445
	Trans-rectal	Identical	---	Identical to K171105 and
K170445
	Trans-vaginal	Identical	---	Identical to K171105 and
K170445
Imaging
modes
Conventional	B-Mode (Harmonic,
Fundamental)	Identical	---	Identical to K171105 and
K170445
	M-Mode	Identical	Identical	Identical
	PW	Identical	---	Identical to K171105 and
K170445
	CW	Identical	---	Identical to K171105 and
K170445
	Color Doppler	Identical	---	Identical to K171105 and
K170445
	Amplitude Doppler	Identical	---	Identical to K171105 and
K170445
	Microvascular (Angio PL.U.S)	---	---	Identical to K171105
Other	Spatial compounding,
Panoramic	Identical	---	Identical to K171105 and
K170445
	SuperSonic Imagine	GE	Echosens	SuperSonic Imagine
	Contrast	Identical	---	Identical to K171105 and
K170445
	Combination of modes	Identical	--- (has specific modes: A-
mode, CAP).	Identical to K171105 and
K170445
	ShearWave Elastography	Identical	VCTE	Identical to K171105 and
K170445
Design
Cart	Mobile cart based product with
control panel and monitor	Identical	Identical	Identical
Controls	Typical ultrasound imaging
controls (gain, depth mode
select...)	Identical	Identical	Identical
Biopsy guide	Available	Identical	---	Identical to K171105 and
K170445
Track	Track 3 (Acoustic Output
Display)	Identical	Identical	Identical
Patient
Contact
Materials	Yes, per ISO 10993-1	Identical	Identical	Identical
Acoustic
Output within
FDA
guidelines	Yes, as per NEMA UD-3	Identical	Identical	Identical

Image Review	Yes	Identical	Identical	Identical
Measurement
Package	Yes	Identical	Identical	Identical
Calculation
Package	Yes	Identical	Identical	Identical
	SuperSonic Imagine	GE	Echosens	SuperSonic Imagine
Report	Yes	Identical	Identical	Identical
General Safety	Conforms to IEC60601-1
60601-1-2, 60601-2-37	Identical	Identical	Identical

Labeling	Conforms to 21 CFR Part 801	Identical	Identical	Identical

18

19

20

21

Note:

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

:. --- means not applicable

22

7) A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

Reference Standard	Tests Performed
IEC 60601-1 3.1 Edition	All applicable electrical, basic safety and essential performance tests.
IEC 60601-1-2 3rd Edition	All applicable testing pertaining to electromagnetic compatibility.
IEC 60601-2-37 2nd Edition	All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstrate compliance with the "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category.

Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.

The above testing confirmed that the Aixplorer® and Aixplorer® Ultimate 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® and Aixplorer® Ultimate Systems to the predicate device(s).

8) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

The subject of this premarket submission required a clinical evaluation by literature route to support substantial equivalence and to widen the indications for use of Aixplore® Ultimate Ultrasound Diagnostic Systems.

9) Conclusion

The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2003) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during 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.