AIXPLORER by SUPERSONIC IMAGINE | FDA 510(k) Summary

The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal and Trans-vaginal.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatic, Urology, Transrectal and Trans-vaginal).

Device Description

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear 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, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Dopler, 3D imaging and for ShearWave™ elastography.

AI/ML Overview

This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for new device performance.

Therefore, many of the requested items (like specific acceptance criteria, sample sizes for test/training sets, number of experts, adjudication methods for ground truth, MRMC studies, and standalone performance) are not detailed in this document because the submission is for a general-purpose ultrasound system showing equivalence rather than a device claiming improved diagnostic performance for specific conditions through new algorithms or features.

However, I can extract the information that is present and explicitly state when information is not available in the provided text.

Here's the breakdown:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy for specific clinical tasks, as it's a submission for a general-purpose ultrasound system establishing substantial equivalence. The "performance" mentioned is primarily related to safety and the functional equivalence of imaging modes and capabilities to predicate devices.

Acceptance Criteria Category (Implied)	Reported Device Performance
Safety - Acoustic Output Limits	Mechanical Index: 1.9 (Maximum)
	TIS/TIB: 0.1 - 4.0 (Range)
	ISPTA(d): 720 mW/cm2
	ISPPA(d): 0 - 700 W/cm2
	"These limits are the same as predicate Track 3 devices."
Safety - Electrical & Physical	"Designed to comply with IEC 60101-1 (2005) and IEC 60601-2-37 (2007)."
Functional Equivalence (Overall)	"Substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness."
Clinical Capabilities	Same B-Mode (grayscale imaging) and Doppler capabilities as predicates.
	Similar harmonic imaging, spatial compound imaging, elastography imaging, and other image post-processing features to predicates.
Material Safety	"Manufactured with materials which have been evaluated and found to be safe for the intended use of the device."
Measurement, Capture, Reporting	Similar capability to predicate devices for performing measurements, capturing digital images, reviewing, and reporting studies.
Manufacturing Compliance	"Manufactured in compliance with approved electrical and physical safety standards."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this is a 510(k) submission primarily demonstrating substantial equivalence to predicate devices based on functional and safety characteristics, it doesn't detail a specific clinical trial with a "test set" in the context of diagnostic accuracy for a new feature. The ShearWave™ elastography mentioned is established as being "similar in capabilities" to predicate devices, rather than through a new, specific clinical performance study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was done. The document focuses on the AIXPLORER® system itself and its equivalence to other ultrasound systems, not on an AI-assisted interpretation component for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This document does not describe performance of an algorithm only in a standalone capacity. The AIXPLORER® is a diagnostic ultrasound system intended for human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. Given the nature of a general ultrasound system 510(k), explicit ground truth definition for a specific diagnostic task is typically not required for substantial equivalence, unless a new diagnostic algorithm with specific performance claims is being introduced.

8. The sample size for the training set

This information is not provided in the document. The document describes a general diagnostic ultrasound system; it does not detail the use or training of a specific AI algorithm.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary

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510(k) Summary of Safety and Effectiveness

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

1) Submitter's name, address, telephone number, contact person

. Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne – Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: 011 33 442 99 24 24

K102041

OCT 1 3 2010

Distributed by: SuperSonic Imagine, Inc. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: +1(425) 686 6380

*** Corresponding Official:

Jacques Souquet Chief Executive Officer Telephone: 011 33 442 99 24 35

Date: 2010/07/13

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: Aixplorer®

Classification:

Regulatory Class: II

Classification Name:	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Substantially Equivalent/Predicate Devices

AIXPLORER® Ultrasound Imaging System (K091970), cleared on 08/12/2009 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010

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4) Description of Device

5) Intended Use

The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

6) Indication for Use

7) Safety Considerations

As a Track 3 ultrasound device, the SuperSonic Imagine AIXPLORER® ultrasound system is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment" AIUM/NEMA 2004a published by the National Electrical Manufacturers Association as UD -3. With respect to limits on acoustic outputs, the SuperSonic Imagine AIXPLORER® ultrasound system complies with the FDA guideline limits set in the September 9, 2008, 510(k) diagnostic ultrasound guidance.

With regard to general safety, the SuperSonic Imagine AIXPLORER® ultrasound system scanner is designed to comply with IEC 60101 - 1 (2005) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance, and IEC 60601 - 2-37 (2007): Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

Mechanical Index	1.9 (Maximum)
TIS/TIB	0.1 - 4.0 (Range)
ISPTA (d)	720 mW/cm2
ISPPA (d)	0 - 700 W/cm2

The device's acoustic output limits are:

The limits are the same as predicate Track 3 devices. These considerations apply to all modes the system offers.

8) Comparison to Predicate Devices

The SuperSonic Imagine AIXPLORER® system and transducers are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness.

The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. .
- The systems have the same clinical indications for use. .

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. The systems have the same B-Mode (grayscale imaging) and Doppler capabilities.
. The systems have similar capability in terms of harmonic imaging, spatial compound imaging, elastography imaging and other image post-processing features to improve the image quality and aid in clinical evaluation and diagnosis.
. The transducers are similar in materials, manufacture and clinical capability.
The systems are manufactured with materials which have been evaluated and found to be safe . for the intended use of the device.
. The systems have acoustic power levels which are below the applicable FDA limits.
The systems have similar capability in terms of performing measurements, capturing digital . images, reviewing and reporting studies.
The systems have been found to be manufactured in compliance with approved electrical and . physical safety standards.

9) Conclusion

The documentation provided demonstrates that:

1. The system and transducers are substantially equivalent to the predicate devices.
1. There are no new questions of safety and effectiveness concerning the SuperSonic Imagine AIXPLORER® ultrasound system and transducers.
1. The ultrasound device has been scientifically evaluated and has been demonstrated to be at least as safe and effective as the predicate devices cited in item 3. The system's acoustic power levels are below the applicable FDA limits.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Jacques Souquet CEO SuperSonis Imaging Les Jardins de la Duranne-bât. E & F, 510 rue René Descartes Aix-en-Provence, 13857 FRANCE

Re: K102041

Trade/Device Name: AIXPLORER® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYN Dated: July 13, 2010 Received: July 19, 2010

Dear Mr. Souquet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the AIXPLORER® Ultrasound System, as described in your premarket notification:

Transducer Model Number

SL15-4 Transducer (1D Linear Array) SC6-1 Transducer (Curved Array) SE12-3 Transducer (Endocavity) SLV16-5 Tranducer (Motorized Linear)

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.

Sincerely yours,

David G. Brown, Ph.D. . . Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) number (if known):

Device Name: AIXPLORER® Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for Use:

Prescription Use _ XX

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 11

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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K162041

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	Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	MPWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P		P	P 1, 2, 3	P 4, 5, 6, 7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N		N	N, 1, 2, 3	N 4, 5, 6, 7
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P	P		P	P, 1, 2, 3	P 4, 5, 6, 7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P		P	P, 1, 2, 3	P 4, 5, 6, 7
	Musculo-skeletal (Superficial)	P	P		P	P, 1, 2, 3	P 4, 5, 6, 7
	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, 2, 3	P 4, 5, 6, 7
	Other (Specify)

N = new indication; P = previously cleared by FDA (K091970).

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave
TM Elastography

3: Combined modes Include: B+ Pulsed Wave

4: Harmonic Imaging

5: Spatial Compounding

6: ShearWaveTM Elastography

7: Imaging Guidance for Biopsies

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Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K: K102041

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510(k) Number (if known):

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA (K091970)

Additional Comments:

1: Cambined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: 8+ Pulsed Wave

. .

4: Harnonic Imaging

5: Spatial Compounding

5: Spallal Compounding
6: ShearWave 14 Elaslography

7: Imaging Guidance for Blopsies

8: Contrasi mode

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Division of Hadiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K

Prescription Use XX OR Over-The-Counter Use _

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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510(k) Number (if known): . .

Device Name: SE12-3 transducer (endocavitary Iransducer)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA (K091970)

Additional Comments:

1; Combined modes include: 8+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

Hamonic Imaging

5: Spatial Compounding

1. Spatial Compounding
  6: ShearWave™ Elastography
  7: Imaging Guidance for Biopsies

. .

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Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

K162041
510K

510K. 1516204

OR Over-The-Counter Use Prescription Use XX

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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510(k) Number (if known):

Device Name: SLV16-5 transducer (molorized linear transducer) Intended Use: Di

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	MPWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	N	N	N		N, 1, 2, 3	N 4, 5, 6,7, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N, 1, 2, 3	N 4, 5, 6,7, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	N	N	N		N. 1, 2, 3	N 4, 5, 6,7. 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N. 1, 2, 3	N 4. 5, 6.9
	Musculo-skeletal (Superficial)	N	N	N		N, 1, 2, 3	N 4, 5, 6,9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N		N, 1, 2, 3	N 4, 5. 6,7,9
Vessel	Other (Specify)
	N = new indication; P = previously cleared by FDA (K091970)
Additional Comments:4: Harmonic Imaging5: Spatial Compounding6: ShearWave " Elastography	1: Combined modes include: B+ Color Flow2: Combined modes include: B+ ShearWave™ Elastography3: Combined modes include: B+ Pulsed Wave				(Division Sign-Off)Division of Radiological Devices	Office of In Vitro Diagnostic Device Evaluation and Safety
7: Imaging Guidance for Biopsies9: 3D imaging			510K
	Prescription UseXX				OR Over-The-Counter Use

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Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.