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, Vasculoskeletal, 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, Peditatin, Uniology, 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 veriety of linear, curved, micro-convex, and motorized linear array intensducers to produce images that 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 diagnostics studies in the form of a report. The system functions in a manner identical to the predicate devices in the the imaging modes: B-Mode, Calleno in a mannel lucinical to the president for the imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided primarily relate to the non-clinical performance of the Shearwave™ elastography mode and are presented as bias and precision measurements compared to nominal shear wave velocities in a phantom. There are no explicit pass/fail thresholds defined in the text, so "acceptance criteria" here refers to the demonstrated performance that the manufacturer is submitting for equivalence.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Example for SLV16-5, 10.4mm target)
Shearwave Velocity Estimation Bias	Minimized, consistent	Target Type I: 6.4%
		Target Type II: -8.6%
		Target Type III: -3.2%
		Target Type IV: 3.7%
Shearwave Velocity Estimation Precision	Minimized, consistent	Target Type I: 2.2%
		Target Type II: 1.8%
		Target Type III: 1.3%
		Target Type IV: 0.9%
Depth Dependence of Shearwave Velocity	Satisfactory agreement across depths	Generally consistent Mean SWV (e.g., for SLV15-6: 2.86 m/s at 5mm, 2.70 m/s at 25mm) with low Standard Deviation (e.g., 0.01-0.05 m/s)
Acoustic Output Limits	Below FDA guideline limits	Mechanical Index: 1.9 (Max)
		TIS/TIB: 0.1 - 4.0 (Range)
		ISPTA(d): 720 mW/cm^2
		ISPPA(d): 0 - 700 W/cm^2

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

Test Set Description: The test set for "Bias and Precision of Shearwave Velocity Estimation" and "Depth Dependence of Elastography Velocity Estimation" consisted of a single CIRS 049A Quality Assurance elasticity phantom. This phantom contains stepped-cylinder targets of four stiffness types (I–IV) and varying diameters (4.1mm, 6.5mm, 10.4mm, 16.7mm).
Sample Size for Measurements: For each target type and diameter within the phantom, five independent shear wave velocity measurements were performed to calculate bias and precision. For the depth dependence test, five measurements were performed per depth for the uniform-elasticity background material.
Data Provenance: The data is non-clinical and was generated in a laboratory setting using a phantom, not from human subjects. The country of origin of the data is not explicitly stated, but the manufacturer is based in France and the data was submitted to the US FDA.

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

Number of Experts: Not applicable. The ground truth for the non-clinical tests was established by the nominal shear wave velocities of the CIRS 049A phantom, which are inherent properties of the phantom material as specified by the phantom manufacturer (CIRS).
Qualifications of Experts: Not applicable, as no human experts were involved in establishing this type of ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" was the known nominal shear wave velocities of the phantom materials. The device's measurements were quantitatively compared against these known values. There was no expert consensus or adjudication process described as the ground truth was inherently defined by the phantom itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical performance data for the elastography mode and claims substantial equivalence to predicate devices based on identical intended use, imaging capabilities, safety, and effectiveness. The enhancement in this submission is merely a display change (a gradiated and adjustable numeric scale next to the color bar in elastography mode). Therefore, a study to measure human reader improvement with AI assistance (which ShearWave elastography is not explicitly described as, but rather an imaging mode) was not performed or necessary for this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance assessment was effectively done for the elastography mode in a non-clinical setting. The tests for "Bias and Precision of Shearwave Velocity Estimation" and "Depth Dependence of Elastography Velocity Estimation" evaluate the algorithm's ability to accurately and precisely measure shear wave velocities in a phantom, independent of a human operator's interpretation. The results are quantitative measurements of the device's output (shearwave velocity estimates) against known phantom properties.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used for the non-clinical performance tests was the nominal shear wave velocities provided by the manufacturer of the CIRS 049A Quality Assurance elasticity phantom. This represents a known, measurable physical property of the test material.

8. The Sample Size for the Training Set

Not applicable / Not provided. This 510(k) summary does not describe any machine learning or AI algorithm that would require a distinct "training set" as understood in that context. The device is an ultrasound imaging system with an elastography mode, and the performance data presented is for the measurement capabilities of this established technology.

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

Not applicable / Not provided. As no training set is described or implied for a machine learning component, the method for establishing its ground truth is not relevant to this submission.

Summary

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510(k) Summary of Safety and Effectiveness

AUG 28 2012

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: 011 33 442 99 24 24

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

Corresponding Official:

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

Date: August 24, 2012

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

Substantially Equivalent/Predicate Devices 3)

AIXPLORER® Ultrasound Imaging System (K091970), cleared August 12, 2009 AIXPLORER® Ultrasound Imaging System (K102041), cleared October 18, 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 AIXELORER® ultrasound system complies with the FDA guideline limits set in the September 0, 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 identical to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness.

・

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The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The systems have the same clinical indications for use. .
The systems have the same B-Mode (grayscale imaging) and Doppler capabilities. .
The systems have similar capability in terms of harmonic imaging, spatial compond imaging, . elastography imaging and other image post-processing features to improve the image quality and aid in clinical evaluation and diagnosis.
. The transducers are identical 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 identical 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.

The SuperSonic Imagine AlXPLORER® system and transducers are identical to the predicate device . identified in K102041; only the display of the device is changed in the elastography mode. A gradiated and adjustable numeric scale, with units, will be added next to the color bar, so that users will be able to change the dynamic range displayed and return repeatedly and consistently to the selected range for the particular patient examination.

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9) Nonclinical Performance Data

The SuperSonic Imagine AIXPLORER® system and transducers are identical to the predicate device identified in K102041; only the display of the device is changed in the preofically one provide device additional non clinical performance data was submitted for determination of substantial equivalnee.

The following non clinical performance tests were conducted to demonstrate the performance of the device in the elastography mode.

9.1 Bias and Precision of Shearwave Velocity Estimation

This test was conducted using a CIRS 049A Quality Assurance elasticity phantom. This phantom contains stepped-cylinder targets of four stiffness types I – IV corresponding to nominal shear wave speeds of 1.6, 2.2, 3.9 and 5.2 m/s of different diameters, embedded in uniform-elasticity background (nominal shear wave speeds of 2.9 m/s).

Shearwave velocity estimation bias was derived as the difference between the mean of five independent shear wave velocity measurements and the nominal shear wave velocity, normalized by the nominal shear wave velocity and expressed as a percentage.

Shearwave velocity estimation precision was derived as the standard deviation of five independent shear wave velocity measurements normalized by the mean of the five independent measurements, and expressed as a percentage.

The tables below document the estimation bias and estimation precision as a function of target size and target stiffness for all transducers where the Elastography mode is available.

			SLV16-5
	TargetType: I	TargetType: II		TargetType: III		TargetType: IV
Target Diameter(mm)	BIAS PRECISION(%) (%)	BIAS	PRECISION(%)	BIAS	PRECISION(%)	BIAS	PRECISION(%)
4.1	21.9 3.9	-7.0	2.2	19.2	2.3	24.1	1.9
6.5	7.6 0.2	-7.8	2.2	-8.7	1.3	12.5	2.2
10.4	6.4 2.2	-8.6	1.8	-3.2	1.3	3.7	0.9
16.7	1.6 0.2	-8.6	1.8	-0.2	1.0	9.5	0.9

SL15-4
	TargetType: I		TargetType: II		TargetType: III		TargetType: IV
Target Diameter(mm)		BIAS (%)	PRECISION (%)	BIAS (%)	PRECISION (%)	BIAS (%)	PRECISION (%)	BIAS (%)	PRECISION (%)
4.1		19.5	0.2	-5.3	0.3	-	-	24.5	2.3
6.5		7.6	0.2	-7.8	2.2	-9.7	0.4	12.5	0.9
10.4		1.6	0.2	-9.4	0.3	-3.7	1.3	-0.9	1.5
16.7		1.6	0.2	-8.6	1.8	5.3	0.4	8.8	1.3

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SL10-2
Target Diameter (mm)	TargetType: I	BIAS (%)	PRECISION (%)	TargetType: II	BIAS (%)	PRECISION (%)	TargetType: III	BIAS (%)	PRECISION (%)	TargetType: IV	BIAS (%)	PRECISION (%)
4.1		25.5	0.2		-4.5	1.7		21.8	1.3		22.2	1.0
6.5		13.5	0.2		-5.3	0.3		10.2	1.1		-9.8	1.7
10.4		7.6	0.2		-5.3	0.3		-0.2	1.0		-0.1	2.0
16.7		1.6	0.2		-5.3	0.3		6.3	1.2		7.2	0.9

SE12-3
	TargetType: I		TargetType: II		TargetType: III		TargetType: IV
Target Diameter(mm)	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)
6.5					-		-
	26.7	1.9	-2.8	2.1	13.7	1.4	17.9	1.9
10.4	7.6	0.2	-6.1	1.8	-5.7	1.3	-0.9	0.8
16.7	1.6	0.2	-5.3	0.3	1.3	1.2	9.9	0.7

SC6-1
Target Diameter(mm)	TargetType: I		TargetType: II		TargetType: III		TargetType: IV
	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)	BIAS(%)	PRECISION(%)
6.5	43.4	0.2	2.1	1.6	27.3	0.4	39.6	1.3
10.4	21.9	2.4	-2.0	1.7	14.2	1.2	22.2	1.0
16.7	5.2	2.8	-7.0	2.2	-7.2	0.0	11.0	3.4

The results of this test demonstrate that the shearwave velocity estimates exhibit high precision for all target types and sizes considered, and are accurate with target sizes compatible to a transidered sis elastography spatial resolution.

9.2 Depth Dependence of Elastography Velocity Estimation

The Depth Dependence Test was conducted using the same CIRS049A phantom as in the Bias and Precision Test described above.

Shearwave velocity estimates were obtained through the uniform-elasticity background material of the CIRS 049A phantom at multiple depths up to the penetration depth of each transducer. Five indent measurements were performed per depth and were used to calculate the sheanwave velocity average and standard deviation values per depth.

The table below provides the results of this test:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

SLV15-6	SL15-4
SL10-2	SE12-3
SC6-1

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DEPTH(mm)	SWVAVG(m/s)	SWVSTD(m/s)	SWVSTD(m/s)	SWVSTD(m/s)	SWVAVG(m/s)	SWVSTD(m/s)	SWVAVG(m/s)	SWVSTD(m/s)	SWVAVG(m/s)	SWVSTD(m/s)
5	2.86	0.05	2.78	0.04	2.80	0.01	2.90	0.01
10	2.80	0.01	2.80	0.01	2.72	0.04	2.80	0.01
15	2.70	0.01	2.68	0.04	2.70	0.01	2.70	0.01
20	2.72	0.04	2.70	0.01	2.70	0.01	2.68	0.01
25	2.70	0.01	2.70	0.01	2.68	0.04	2.64	0.05
30					2.70	0.01			2.90	0.01
35					2.70	0.01			NA	NA
40					2.80	0.01			2.70	0.01
50								2.70	0.01
60								2.60	0.01
70								2.60	0.01

The results of this test demonstrate that the shearwave velocity estimates exhibit satisfactory agreement for all transducers and depths considered.

10) 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 demonstrated to be as safe and effective as the predicate devices identified in item 3.

The system's acoustic power levels are below the applicable FDA limits.

SUPERSONIC IMAGINE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 28 2012

Mr. Jacques Souquet Chief Executive Officer SuperSonic Image, S.A. Les Jardins de la Duranne - Bat. E & F 510, rue Rene Descartes AIX-EN-PROVENCE CEDEX 13857 FRANCE

Re: K112255

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, IYO, and ITX Dated: June 26, 2012 Received: June 26, 2012

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

SL 15-4 (1D linear array)	SE 12-3 (endocavitary)
SC6-1 (curved array)	SLV16-5 (motorized linear

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

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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/CDRH/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 Brendan O'Leary at (301) 796-6898.

Sincerely Yours.

Amherst D. Ohm for

Janine M. Morris 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:

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.

Prescription Use XX

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

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

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

(Division Sign-Off)
Division of Radiological Devices

510k

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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:

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)	P	P		P		P, 1, 2, 3	P, 4, 5, 6,7,8
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 78
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P		P		P, 1, 2, 3	P, 4, 5, 6,7,8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	Trans-vaginal	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P		P		P, 1, 2, 3	P, 4, 5, 6,7,8
	Musculo-skeletal (Superficial)	P	P		P		P, 1, 2, 3	P, 4, 5, 6,7,8
	Intravascular
	GYN	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7,8
	Pelvic	P	P		P		P, 1, 2, 3	P, 4, 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, 2, 3	P, 4, 5, 6,7,8
Vessel	Other (Specify)	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7

P = previously cleared by FDA (K102041)

Additional Comments:

510k

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

h
(Division Sign Off)

ഗ്ഗം

(Division Sign-Off) Olvision of Radiological Devices

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3: Combined modes include: B+ Pulsed Wave

4: Harmonic Imaging

5: Spatial Compounding

്

7: Imaging Guidance for Biopsies

8: 3D Imaging

Prescription Use XX____ OR Over-The-Counter Use __________________________________________________________________________________________________________________________

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of 11

signature

112255

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510(k) Number (if known):

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

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	P	W	D	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	P		P				P	P, 1, 2, 3	P 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)

P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Harmonic Imaging

21 %

Spatial Compounding

b: Shearwave Elastography

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

Jmull D. O'R

OIVD

(Division Sign-Off) ર્જિતિ Division of Radiological Devices

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Prescription Use XX______ OR Over-The-Counter Use _

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 5 of 11 .

Michael D. O'Brien
K112255

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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
	Abdominal (including urology)	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	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	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	Pelvic	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7
	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)	P	P		P		P, 1, 2, 3	P, 4, 5, 6, 7

で

OR Over-The-Counter Use

ت تري

P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Combined modes include: D + Color Friow
2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Harmonic Imaging

5: Spatial Compounding
TM

5: Spatial Compounding
6: ShearWave™ Elastography

7: Imaging Guidance for Biopsies

Prescription Use

Michael D. Okerlund

(Division Sign-Off) of Radiological Devices

210k

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) of the may Page 7 of 11 ' 412255

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

510(k) Number (if known):

Device Name: SE12-3 transducer (endocavitary transducer)

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

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	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...)	P	P			P	P, 1, 2, 3	P, 4, 5, 6,7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P			P	P, 1, 2, 3	P, 4, 5, 6,7
	Trans-vaginal	P	P			P	P, 1, 2, 3	P, 4, 5, 6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial).
	Intravascular
	GYN	P	P			P	P, 1, 2, 3	P, 4, 5, 6,7
	Pelvic	P	P			P	P, 1, 2, 3	P, 4, 5, 6,7
	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, 2, 3	P, 4, 5, 6,7

P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Combined modes include: B+ ShearWave™ Elastography

Combined modes include B+ Pulsed Wave

(Division Sign-Off) on of Radiological Devices OTVO

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

Page 9 of 11

4: Harmonic Imaging 5: Spatial Compounding
6: ShearWave™ Elastography 7: Imaging Guidance for Biopsies

Prescription Use XX_____ OR Over-The-Counter Use _

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Murld D'Ohm
F112255

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

510(k) Number (if known):

Device Name: SLV16-5 transducer (motorized linear transducer)

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

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

P = previously cleared by FDA (K102041)

Additional Comments:

510k

1: Combined modes include: B+ Color Flow

2: Combing a modes include: B ShearWave™ Elastography

స్ట్ ਾ ਕਿ

3.70pmbined modes include: B+P Ised Wave

(Division Sign-Off)

Division of Radiological Devices OTVE

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

Page 11 of 11

4: Harmonic Imaging 5: Spatial Compounding
6: ShearWave™ Elastography 7: Imaging Guidance for Biopsies 8: 3D imaging

Prescription Use XX_____ OR Over-The-Counter Use _______________________________________________________________________________________________________________________

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael D Othen

611225-5

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.