The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult, Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the oction to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subcinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Device Description

The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

AI/ML Overview

This document, a 510(k) submission for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, focuses on establishing substantial equivalence to previously cleared devices rather than demonstrating performance against specific acceptance criteria through a dedicated study for the VTQ feature.

Here's an breakdown based on the provided text, highlighting the absence of some requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report device performance in the context of a hypothesis-driven study for the VTQ feature. Instead, it argues for substantial equivalence based on the technological characteristics and intended use being similar to predicate devices. The closest to "performance" is the comparison of features between the Siemens VTQ and the Supersonic Imagine Aixplorer, where the VTQ is positioned as offering a "more consistent shear wave velocity estimation based on our experience in in-vivo studies" and emphasizing its direct measurement of shear wave velocity versus the predicate's Young's modulus.

Feature / Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (VTQ)
Comparable Exam Types	Abdomen, Breast, Thyroid	Abdomen, Breast, Thyroid (Matches Predicate)
Operating Mode	Single Frame	Single Frame (Different from Predicate's "Low Frame Rate Real Time")
Cool Down Period	Variable (~1-3 sec)	Yes (Matches)
Push Pulse Sequence	Dual Push Beams	Dual Push Beams (Different from Predicate)
Multiple Push Pulse Focal Zones	No (Single focal position tracks with ROI)	No (Matches)
Two Dimensional Display with Elasticity ROI	No	No (Different from Predicate - Predicate not cleared in USA)
Localized Quantitative Shear Wave Velocity Measurement	Yes - Cleared in USA	Yes (Matches, and seeks clearance for point measurements)
Localized Quantitative Young's Modulus Measurement	No	No (Different from Predicate - Predicate not cleared in USA)
Localized Shear Wave Velocity Measurement Area	6C1 HD, 4C1, 4V1: 10mm (h) x 6mm (w); 9L4: 5mm (h) x 6mm (w)	Matches specified dimensions
Shear Wave Velocity Measurement Range	0.5-5.5 m/sec (6C1 HD, 4C1, 4V1); 0.5-8.4 m/sec (9L4)	Matches specified ranges
Color Coded Shear Wave Velocity Display	No	No (Different from Predicate)

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

The document explicitly states: "The S2000, S3000 and Aixplorer use the same technology and principles as existing devices, clinical data is not required." This indicates that no specific test set of patient data was used to demonstrate the performance of the VTQ feature against acceptance criteria. The "experience in in-vivo studies" mentioned in Note 1 is vague and not described as a formal clinical study with a defined sample size or provenance.

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

Since no specific test set was used for a performance study, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method

Not applicable as no formal test set and ground truth establishment study were performed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or referenced. The submission is focused on demonstrating substantial equivalence of the device, not comparative effectiveness or human reader improvement with AI.

6. Standalone Performance (Algorithm Only)

The document does not describe a standalone performance study for the VTQ algorithm. The comparisons made are about the operational characteristics and measurement capabilities of the device as a whole, rather than the isolated performance of an algorithm. The "more consistent shear wave velocity estimation based on our experience in in-vivo studies" might hint at internal testing, but it's not a formally described standalone study.

7. Type of Ground Truth Used

No specific ground truth type (e.g., pathology, outcomes data) is mentioned as being used for a performance study of the VTQ feature, given that clinical data was not deemed necessary for the 510(k) submission.

8. Sample Size for the Training Set

There is no mention of a training set or its sample size. This submission is for a medical imaging device with software features, not an AI/ML device that typically requires extensive training data.

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

Not applicable, as no training set is mentioned.

Summary of the Document's Approach:

The 510(k) submission for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, particularly concerning the VTQ feature, relies primarily on demonstrating substantial equivalence to existing, legally marketed predicate devices (specifically Supersonic Imagine Shearwave Elastography). This is achieved by:

Comparing technological characteristics: Detailing how the VTQ feature's operational modes, measurement capabilities, and technical specifications are similar to or offer advancements over the predicate device, while maintaining the same fundamental principles of shear wave elastography.
Aligning with intended use: Showing that the expanded applications and features (including VTQ) fall within the established indications for use of diagnostic ultrasound systems.
Compliance with safety standards: Highlighting adherence to various international and national safety and quality standards (UL 60601-1, IEC 60601-2-37, ISO 10993-1, etc.).

Crucially, the submission explicitly states that clinical data (and thus formal studies with acceptance criteria, test sets, ground truth, etc.) was not required for this determination of substantial equivalence because the technology and principles are established. The "studies" referenced are primarily previous 510(k) clearances for the predicate devices and the base S2000/S3000 systems, along with adherence to voluntary standards. "In-vivo studies" are mentioned in a qualitative sense to support claims of consistency but are not presented as formal clinical trials.

Summary

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KB1164
page 1 of 7

S2000 and S3000 VTQ 510(k) Submission

DEC 2 4 2013

510(k) Summary Prepared April 17, 2013

Siemens Medical Solutions, Inc., 1. Sponsor: Ultrasound Division 685 East Middlefield Road Mountain View, California 94043

Contact Person:	Shelly Pearce
	Telephone: (650) 694-5988
	Fax: (650) 694-5580

1. Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems
- Common Name: Diagnostic Ultrasound System

Classification:

Regulatory Class: ll Review Category: Tier II Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Ultrasound Catheter	FR # 870.1200	Product Code OBJ

3. Legally Marketed Predicate Devices

The Acuson S2000 and S3000 Ultrasound Systems are substantially equivalent to the company's own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K122825, K112255, K121329)

4. Device Description:

5. Intended Use

The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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Siemens Medical Solutions, Inc.	S2000 and S3000 VTQ
Ultrasound Division	510(k) Submission

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

	Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	SupersonicImagineK112255 /K121329
	Indications for Use:
■	Fetal	√	√	√	√
■	Abdominal	√	√	√	√	√
■	Intraoperative abdominal andvascular	√	√	√	√
■	Intraoperative neurological	--	--	--	--	--
■	Pediatric	√	√	√	√	√
■	Small Organ	√	√	√	√	√
■	Neonatal cephalic	√	√	√	√
■	Adult Cephalic	√	√	√	√
■	Cardiac	√	√	√	√
■	Trans-esophageal	√	√	√	√
■	Transrectal	√	√	√	√	√
■	Transvaginal	√	√	√	√	√
■	Peripheral vessel	√	√	√	√	√
■	Laparoscopic	--	--	--	--	--
■	Musculo-skeletal (conventional)	√	√	√	√	√
■	Musculo-skeletal (superficial)	√	√	√	√	√
	Center Frequencies Supported:
■	2.0 MHz	√	√	√	√	√
■	3.0 MHz	√	√	√	√	√
■	3.2 MHz	√	√	√	√	√
Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	SupersonicImagineK112255/K121329
• 3.3 MHz	√	√	√	√	√
• 4.2 MHz	√	√	√	√	√
• 4.4 MHz	√	√	√	√	√
• 4.8 MHz	√	√	√	√	√
• 5.0 MHz	√	√	√	√	√
• 5.2 MHz	√	√	√	√	√
• 6.0 MHz	√	√	√	√	√
• 6.5 MHz	√	√	√	√	√
• 6.9 MHz	√	√	√	√	√
• 9.5 MHz	√	√	√	√	√
• 10.0 MHz	√	√	√	√	√
Modes:
• B	√	√	√	√	√
• Parallel processing in B mode	√	√	√	√	√
• M	√	√	√	√
• PWD (Pulsed Wave Doppler)	√	√	√	√	√
• CWD (Continuous Wave Doppler)	√	√	√	√	√
• D (Color Doppler)	√	√	√	√	√
• Amplitude Doppler	√	√	√	√	√
• Combined (BMDC)	√	√	√	√	√
Features:
• Quad processing in color	√	√	√	√
• Native™ tissue harmonic imaging	√	√	√	√
• SieScape™ panoramic imaging	√	√	√	√
• Color SieScape™ panoramicimaging	√	√	√	√
• 3-Scape™ real-time 3D imaging	√	√	√	√
• fourSight™ 4D transducertechnology	√	√	√	√
• TEQ™ ultrasound technology	√	√	√	√
• Extend imaging technology	√	√	√	√
• Cardiac Imagingphysiological signal display	√	√	√	√
• syngo ® Auto OB measurements	√	√	√	√
• Advanced SieClear™ spatialcompounding	√	√	√	√
• STIC (Fetal Heart Imaging)	√	√	√	√
• Amnioscopic rendering	√	√	√	√
• Cadence contrast agent imaging	√	√	√	√
• Clarify™ vascular enhancementtechnology	√	√	√	√
• eSie™ Touch elasticity imaging	√	√	√	√	√
• syngo ® Auto Left heart	√	√	√	√
• syngo ® Velocity Vector Imaging	√	√	√	√
• Semi Auto-segmentation (eSieCalc)	√	√	√	√
Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	SupersonicImagineK112255 /K121329
Custom Tissue Imaging / Speed ofSound	√	√	√	√
AHP	√	√	√	√
VTQ	√	√			√
18L6HD Transducer	√	√	√	√
6C1HD Transducer	√	√	√	√
8C3HD Transducer		√	√
Monitor: FPD	√	√	√	√	√
Output Display Standard (Track 3)	√	√	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√	√	√	√

6. Summary of Technological Characteristics - New Device Compared to Predicate

S2000/3000 510(k) Submission

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S2000 and S3000 VTQ 510(k) Submission

S2000/3000 510(k) Submission

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S2000 and S3000 VTQ 510(k) Submission

Shear Wave Elasticity Imaging Software	VTQ	SupersonicImagineAixplorer	Comments
Comparable Exam Types	Abdomen,Breast,Thyroid	Abdomen,Breast,Thyroid
Transducer for same Exam Types	6C1 HD,4C1, 4V1,9L4	SC6-1SL15-4
Operating Mode	Single Frame	Low FrameRate RealTime	Note 1
Cool Down period before live imagingresumes	Yes (variable.~1-3 sec)	No	Note 1
Push Pulse sequence	Dual PushBeams: oneon each sideofmeasurementROI	Low (variablewith FOVsize)ReferenceFigure 13 inSupersonicWhite Paper	Note 1
Multiple Push Pulse Focal Zones	No (Singlefocal positiontracks withROI locationin depth)	"Mach Cone"	In both cases, radiation force uniformity ismaintained with depth by optimizing push beamfocus at region of interest. "Mach Cone" is theSupersonic term for compound transmit focusing"Supersonic Imagine has implemented a twodimensional image display representing shearwave speed or Young's modulus. The region ofinterest size is adjustable within limits. A potentialadvantage is the ability to visualize variability ofthe elasticity parameter over a wider area ofinterest, however this is visual reference withoutquantification of variance. Outside the USA, theability to get a mean value is provided for thelarger area or with reduced measurement ROI
Two Dimensional Display with ElasticityRegion of Interest	No	Yes	size, a localized value. This feature is not clearedin the USA. VTQ provides a mean shear wave
			speed over a predefined region of interest that isnot adjustable. For the 4C1, 6C1 HD and 4V1abdomen transducers, the ROI size is 10mm x5mm. For the 9L4 transducer, the ROI size is 5 x5 mm. Multiple measurements can be made overlarger areas and statistics for Mean, Median.Standard Deviation and IQR (Interquartile range)are provided for analyzing multiplemeasurements. There is no evidence to suggestone method is more accurate than the other,therefore we believe they are equivalent in clinicaluse."
Localized Quantitative Shear WaveVelocity measurement	Yes	Yes -Predicate notcleared in theU.S.A.
Localized Quantitative Young's Modulusmeasurement	No	Yes -Predicate notcleared in theU.S.A.	Supersonic Imagine has implemented the shearwave velocity scale in the color bar whichindicates relative shear wave speed in the imageand has been cleared in the U.S. Young'smodulus is not cleared. Siemens VTQ isequivalent to Supersonic except Siemens isrequesting clearance for point measurements inaddition to displaying shear wave velocity on thecolor bar. When Young's modulus is displayed(kPa), assumptions are made regarding tissuedensity and viscosity that may not be correct in awide range of biological tissues and is thereforean indirect measurement. Shear wave velocity isa direct measurement.
Localized Shear Wave Velocitymeasurement area	6C1 HD,4C1, 4V1:10mm(height) by 6mm (width)9L4: 5mm(height) by 6mm (width)	Yes -Predicate notcleared in theU.S.A.	With VTQ, shear wave velocity estimates mustpass a confidence interval check (≥0.8) to displaya value, otherwise an "x.xx" result is displayed.
Shear Wave Propagation "Movie" (clip)	No	Yes	The Supersonic shear wave propagation movieprovides information specific to theirimplementation of shear wave imaging, as notedin Note 1.
Shear Wave Velocity Measurement Range	0.5-5.5 m/sec(6C1 HD,4C1, 4V1)0.5-8.4 m/sec(9L4)	SC6-1: 0-10m/sec(default 0-3.2m/sec)SL15-4: 0-10m/sec	Siemens has chosen a lower velocity cutoff of 0.5m/s to avoid potential erroneous shear wavevelocity estimates. In in-vivo studies, shear wavevelocities below 0.5 m/s have not beenencountered so there is no impact on clinicalefficacy. For abdomen (liver) applications, inseveral in-vivo studies the maximum recordedvalues did not exceed 4.4 m/sec.
Color Coded Shear Wave Velocity Display	No	Yes
Adjustable Maximum and MinimumVelocity Scale	No	Yes
In Color Code, Red is 'stiff' and blue is'soft'	N/A	Yes
Color map is transparent over B modedisplay	N/A	Yes
Other system features:
B Mode Imaging	Yes	Yes
Pulse Wave Doppler Imaging	Yes	Yes
Color Flow Doppler Imaging	Yes	Yes
Spatial Compound Imaging	Yes	Yes
Speckle Reduction Image Processing	Yes	Yes
Tissue Harmonic Imaging	Yes	Yes

S2000/3000 510(k) Submission

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S2000 and S3000 VTQ 510(k) Submission

S2000/3000 510(k) Submission

Page 11 of 64

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S2000 and S3000 VTQ 510(k) Submission

Note 1:

There are differences in push pulse sequencing and shear wave detection between the predicate device (Supersonc Aixplorer) and Siemens VTQ. Siemens uses focused push beams on each side of the measurement ROI and a fixed number of closely spaced focused detection beams resulting in higher signal to noise ratio in shear wave imaging than the predicate device. A reduced push beam mechanical index is used on the Aixplorer as compared to the constant value of 1.7 with VTQ, which allows pseudo-real time operation on the Aixplorer of approximately 1 frame per second. The user is required to compound the image at the region of interest over several seconds with the Aixplorer to allow the image to "build up" over several frames to improve signal to noise ratio. VTQ is a single frame image acquisition that allows higher signal to noise ratio without image compounding and generates a more consistent shear wave velocity estimation based on our experience in in-vivo studies.

7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

UL 60601-1, Safety Requirements for Medical Equipment .
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards l
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive .
Safety and EMC Requirements for Medical Equipment .
- · EN/IEC 60601-1
- · EN/IEC 60601-1-1
- EN/IEC 60601-1-2 .
I IEC 1157 Declaration of Acoustic Power
. ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged.

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

The S2000, S3000 and Aixplorer use the same technology and principles as existing devices, clinical data is not required.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is

S2000/3000 510(k) Submission

{6}------------------------------------------------

designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the devices are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

S2000/3000 510(k) Submission

Page 13 of 64

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

December 24, 2013

Siemens Medical Solutions USA, Inc. c/o Ms. Shelly Pearce Regulatory Affairs 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K131164

Trade/Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: November 19, 2013 Received: November 22, 2013

Dear Ms. Pearce:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

CW2 9L4 Linear Array 6C2 Curved Array 4VI Phased Array 7CF2 Curved Array 8V3 Phased Array EV8C4 V7M TEE

CWS 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4V Ic Phased Array 8C3HD Curved Array ACUNAV 8F

EC9-4 Curved Array 4PI Phased Array 6CIHD Curved Array 14L5 SP Linear Array V5Ms Multiplane TEE ୧୮3 18L6 HD Linear Array ACUNAV 10F

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Page 2-Ms. Pearce

..............................................................................................................................................................................

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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetv/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica|Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Samung Hi. Mesgo

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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1.3 Indications for Use

K131164 A. 510(k) Number (if known):

Device Name: S2000 and S3000 Diagnostic Ultrasound Systems

Indications for Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

currence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Semung M. Mase

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k).

Page 1 of

S2000/3000 510(k) Submission

Page 17 of 64

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.