The 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, 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 Ultrsound 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.

Device Description

AI/ML Overview

The provided document is a 510(k) premarket notification for the Siemens Acuson S3000 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to prove novel acceptance criteria.

Therefore, the document explicitly states that clinical data is not required because the S3000 uses the "same technology and principles as existing devices." This means there isn't a specific study outlined in this submission that defines and proves novel acceptance criteria for the device's performance through clinical trials. Instead, the "acceptance criteria" are implied by conformance to existing safety and performance standards for diagnostic ultrasound systems and demonstrating substantial equivalence to predicate devices already on the market.

Given this, I cannot provide detailed answers to many of your specific questions, as they pertain to clinical studies with ground truth establishment, expert adjudication, and statistical performance metrics, which are not typically part of a 510(k) submission for a device demonstrating substantial equivalence to well-established technology like an ultrasound system.

However, I can extract the information that is present and relevant to the "acceptance criteria" and "study" as implied by the 510(k) process.

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

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of novel acceptance criteria with reported performance from a specific clinical study for this device. Instead, the acceptance criteria are met by:

Conformance to established safety and performance standards.
Demonstration of substantial equivalence to predicate devices (Acuson Antares and S2000 Ultrasound Systems, and specific transducers from those systems). The document implies that the performance of the S3000 is "substantially equivalent" to these cleared devices, meaning it performs as well as, or comparably to, devices already deemed safe and effective.

The table below outlines the general characteristics and features of the Acuson S3000 compared to its predicate devices, demonstrating how it meets the "acceptance criteria" of being substantially equivalent. "Reported device performance" in this context refers to the presence of capabilities and adherence to standards, aligning with the predicates.

Feature / Characteristic	Acceptance Criteria (Implied by Predicate Equivalence & Standards Conformance)	Reported Device Performance (Acuson S3000)
Indications for Use	Must align with or be a subset of predicate device indications.	Broad range of applications (Fetal, Abdominal, Cardiac, Vascular, etc.), consistent with predicates. Explicitly lists all indications as "√" (included) or "N" (new, but implicitly equivalent by technical characteristics).
Center Frequencies	Must support a range of clinically relevant frequencies similar to predicates.	Supports frequencies from 2.0 MHz to 10.0 MHz, consistent with predicates.
Modes	Must support standard ultrasound imaging modes (B, M, Doppler, etc.).	Supports B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Combined modes, consistent with predicates.
Special Features	Must include features similar to or enhanced but equivalent to predicates.	Includes various advanced features like Quad processing in color, Native™ tissue harmonic imaging, SieScape™ panoramic imaging, 3-Scape™ real-time 3D, fourSight™ 4D, TEQ™ ultrasound, syngo® Auto OB measurements, Advanced SieClear™, STIC, Amnioscopic rendering, Cadence contrast agent imaging, Clarify™ vascular enhancement, eSie™ Touch elasticity imaging, syngo® Auto Left heart, syngo® Velocity Vector Imaging, Semi Auto-segmentation, Custom Tissue Imaging/Speed of Sound, AHP, and 19" FPD monitor. Many are marked as also present in the K111674 S2000 predicate.
Biocompatibility	Must conform to ISO 10993-1.	"Tested to ISO 10993-1"
Electrical Safety	Must conform to UL 60601-1.	"UL 60601-1 Certified"
Acoustic Output	Must conform to AIUM/NEMA UD-3 and UD-2.	Device has been evaluated for acoustic output and conforms to these standards.
Cleaning/Disinfection	Must meet established effectiveness for cleaning and disinfection.	Device has been evaluated for cleaning and disinfection effectiveness.
EMC/Mechanical Safety	Must conform to IEC 60601-1-2 and other relevant IEC standards.	Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2.
Quality System	Manufacturer's process must conform to 21 CFR 820 and ISO 13485:2003.	"The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards."

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

The document explicitly states: "Since the S3000 uses the same technology and principles as existing devices, clinical data is not required." Therefore, there is no test set of clinical data used in this 510(k) submission, and consequently, no relevant information on sample size or data provenance. The assessment for substantial equivalence is based on technical comparisons, non-clinical tests (safety, EMC, etc.), and adherence to established standards.

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)

As no clinical test set was required or submitted, there is no information provided on experts establishing ground truth.

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

As no clinical test set was required or submitted, there is no information provided on an adjudication method.

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

No MRMC comparative effectiveness study was conducted or reported in this 510(k) submission. This is a premarket notification for an ultrasound system, not an AI-powered diagnostic device requiring such a study for clinical effectiveness. The document also does not mention AI assistance for human readers in its description of features.

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

This refers to an ultrasound system, not a standalone algorithm. Performance is assessed as a complete system, and no mention of a standalone algorithm (without human operation) is made or relevant here.

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

Since no clinical studies with test sets were performed, no ground truth types are mentioned in this submission. The "ground truth" for the device's acceptable performance is implicitly derived from its adherence to safety standards and its substantial equivalence to previously cleared devices.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI models. This 510(k) is for a diagnostic ultrasound system based on established technology, not an AI/ML-driven device that typically undergoes "training."

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

As no "training set" (in the AI/ML context) is discussed, there is no information provided on how ground truth for such a set was established.

Summary

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K121138

MAY 1 7 2012

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Siemens Medical Solutions, Inc. Ultrasound Division

S3000 Ultrasound System 510(k) Submission

510(k) Summarv Prepared March 19, 2012

Sponsor:

Siemens Medical Solutions, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person:

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

Device Name: Acuson S3000™ Diagnostic Ultrasound System

Diagnostic Ultrasound System Common Name:

Classification:

Regulatory Class: = 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 S3000™Ultrasound System is substantially equivalent to the company's own Acuson Antares and S2000 Ultrasound Systems.

4. Device Description:

The S3000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and 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, M-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. It is substantially equivalent to our current S2000 product (K111674, K093812, K090334, K072786, K081148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 10F (K071234) transducers. These predicates are legally marketed devices.

5. Intended Use

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Feature / Characteristic	Acuson S3000	Acuson S2000 K072786	Acuson S2000 K093812	Acuson S2000 K090334	Acuson S2000 K111674
Indications for Use:
■ Fetal	√	√	√	√	√
■ Abdominal	√	√	√	√	√
■ Intraoperative abdominal and vascular	√	√	√	√	√
■ 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	√	√	√	√	√
■ 3.3 MHz	√	√	√	√	√
■ 4.2 MHz	√	√	√	√	√
Feature / Characteristic	Acuson S3000	Acuson S2000 K072786	Acuson S2000 K093812	Acuson S2000 K090334	Acuson S2000 K111674
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 TM tissue harmonic imaging	√				√
SieScape TM panoramic imaging	√				√
Color SieScape TM panoramic imaging	√				√
3-Scape TM real-time 3D imaging	√				√
fourSight TM 4D transducer technology	√				√
TEQ TM ultrasound technology	√				√
Cardiac Imaging physiological signal display	√				√
syngo ® Auto OB measurements	√				√
Advanced SieClear TM spatial compounding	√				√
STIC	√				√
Amnioscopic rendering	√				√
Cadence contrast agent imaging	√				√
Clarify TM vascular enhancement technology	√				√
eSie TM Touch elasticity imaging	√				√
syngo® Auto Left heart	√				√
syngo ® Velocity Vector Imaging	√				√
Semi Auto-segmentation	√				√
Custom Tissue Imaging / Speed of Sound	√				√
AHP	√				√
Monitor: 19" FPD	√				√
Feature / Characteristic	AcusonS3000	AcusonS2000K072786	AcusonS2000K093812	AcusonS2000K090334	AcusonS2000K111674
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

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

The device has been evaluated for acqustic 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 "
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive ■
Safety and EMC Requirements for Medical Equipment 체
- . 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 I

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.

Since the S3000 uses 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 quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is 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 S3000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The overall design is simple and conveys a sense of official government branding.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Third Party Consultant Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

MAY 1 7 2012

Re: K121138

Trade/Device Name: S3000TM Diagnostic 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: May 10, 2012 Received: May 14, 2012

Dear Mr. Job:

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 S3000™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 4P1 Phased Array 6C2 Curved Array

4C1 Curved Array 6C1HD Curved Array 8C3HD Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved array mechanical 3D

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9EVF4 Curved Array V5Ms Multiplane TEE 18L6 HD Linear Array 8V3 Phased Array 4V1c Phased Array

રા રે -EV8C4 V7M TEE AcuNav 8F Ultrasound Catheter AcuNay 10F Ultrasound Catheter

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 (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/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 Jeffrey J. Ballyns at (301) 796-6105.

Sincerely Yours.

Andres D'Okon for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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S3000 Ultrasound System 510(k) Submission

1.3 Indications for Use

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

Device Name: S3000™Diagnostic Ultrasound System

Indications for Use: ·

The 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 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".

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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arunl Doth

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 6121138

Page 1 of

S3000 510(k) Submission

Page 14 of 59

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1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

ACUSON S3000 Ultrasound System

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 13, 16
Intraoperative(Note 9)		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 14
IntraoperativeNeurological		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 14
Pediatric		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ(Note 1)		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10
Cardiac		N	N	N	N	N	N		BMDC	Note2,3,4,5,6,7,8,10,15
Trans-esophageal		N	N	N	N	N	N		BMDC	Note 4
Transrectal		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14
Transvaginal		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC	Note 2,3,4,5,6,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14
Other (specify)Neonatal Cardiac		N	N	N	N	N	N		BMDC	Note 3,4,6, 10

N = new indication; P = previously cleared by FDA K063085, K072786, K081148, K092142, K090334, K111674

For example: breast; testes, thyroid, penis, prostate, etc. Note 1

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 9 For example: vascular, abdominal

Note 11 Advanced Sieclear spatial compounding

eSie™ Touch elasticity imaging / FTI Note 14

Custom Tissue Imaging Note 16

Note 4	Tissue Equalization Technology
Note 6	Cadence contrast agent imaging
Note 8	Power SieScape panoramic imaging
Note 10	Clarify VE vascular enhancement technology
Note 13	STIC
Note 15	AHP

Note 2 Ensemble tissue harmonic imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRA, Office of In Vite Diagnostic Devices (OIVD) Prescription Use. Bart 1 OER 801 Submart D)

(Division Sign-Off) Bivision of Radiological Devices Offise of In Vitro Diagnostic Device Evaluation and Safety

	S3000 510(k) Submission
--	-------------------------

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S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

CW2 Probe for use with ACUSON S3000

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal				P
Abdominal				P
Intraoperative(Note 9)				P
IntraoperativeNeurological
Pediatric				P
Small Organ(Note 1)				P
Neonatal Cephalic				P
Adult Cephalic				P
Cardiac				P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel				P
Laparoscopic
Musculo-skeletalConventional				P
Musculo-skeletalSuperficial				P
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803; K072786, K081148, K082142, K111674

Additional Comments:

RIOK

For example: breast, testes, thyroid, penis, prostate, etc. Note 1 · Note 9 For example: vascular, abdominal

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

(Division Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: CW5 Probe for use with ACUSON S3000

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological					P
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal									i .
Transvaginal
Transurethral
Intravascular
Peripheral vessel				P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K111674

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note a For example: vascular, abdominal

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

(Division Sign-Off)

Division of Radiological Device: Evaluation and Sefat

Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K121138

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S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

EC9-4 Curved Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5, 6, 7,8,10,11,14
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K111674

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FT1

(PLEASE DO NOT W

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

Division of RadiologicalDomagarrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vito Diagnosic Device Evauation and Safescription Use (Part 21CFR 801 Subpart D)

510K. Klaii38

S3000 510{k) Submission

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

9L4 Linear Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14,16
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic		P	P	P		P	P
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 15 AHP

Note 16 Custom Tissue Imaging

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138

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

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

14L5 Multi-D Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8 Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear spatial compounding
Note 11 eSie™ Touch elasticity imaging / FTI Note 14
Note 16 Custom Tissue Imaging

Mum D. O'the
(Division Sign-Off)

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

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

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if.known):

Device Name: Intended Use:

4P1 Phased Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Pre

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K121/38

S3000 510(k) Submission

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C2 Curved Array Transducer for use with ACUSON $3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K080334, K093812, K111674

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

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

(Division Sign-Ot) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological Devices Prescription Use (Part 21CFR 801 Subpart D)
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K12138

S3000 510(k) Submission

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4C1 Curved Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10, 11, 14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ		P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10

Note 10 Clarity VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

Note 16 Custom Tissue Imaging

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices Office of In Evaluation and Safety

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

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C1HD Curved Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10, 11, 14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ		P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging Power SieScape panoramic imaging
Note 8 Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

(Division Sign-Off)
Division of Radiological Devices

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

510K. K121138

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

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 8C3HD Curved Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ		N	N	N		N	N		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N.		N	N		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K#

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging. Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging / FTI Note 14
Note 16 Custom Tissue Imaging

(Division Sign-Off)

of Radiological Device tic Device Evaluation and Safety

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

રાજ્ય

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

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2
SieClear multi view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging .. .
Note 7 B&W SieScape panoramic imaging Power SieScape panoramic imaging
Note 8 Clarify VE vascular enhancement technologyfice of In Note 10
Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging / FTI Note 14
Note 16 Custom Tissue Imaging

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Klal38

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

510K

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

S3000 510(k) Submission

Page 26 of 59

{19}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

10V4 Phased Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P.	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138

S3000 510(k) Submission

Page 27 of 59

{20}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Indications For Use: 14L5 SP Linear Array Transducer for use with ACUSON $3000 Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 9)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,6,7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K111674

Additional Comments: -

For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
For example: vascular, abdominal Note 9
Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear spatial compounding Note 11
Note 14 eSie™ Touch elasticity imaging / FTI

Note 15 AHP Note 16 Custom Tissue Imaging

A. A. D'Ohm

(Division Sion-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K

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

{21}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

7CF2 Curved array mechanical 3D transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
151138

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

{22}------------------------------------------------

30 of 3658

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

9EVF4 Curved Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
ConventionalMusculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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Office of In tic Device Evaluation and Safet

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510K

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

S3000 510(k) Submission

{23}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

V.5Ms Multiplane TEE Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P	P		BMDC	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334, K093812, K111674

Additional Comments: Tissue Equalization Technology Note 4

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138

{24}------------------------------------------------

$3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

18L6 HD Linear Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Other (specify)

N = new indication; P = previously cleared by FDA K081148, K082142, K090334, K093812, K111674

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 15 AHP

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

510K K12138

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{25}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): ·

Device Name: Intended Use:

8V3 Phased Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 3,4,6
Trans-esophageal
Transrectal
Transvaginal
Transurethral						P
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K082142, K111674

Additional Comments:

Note 2 Ensemble tissue harmonic imaqing

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Part 21CFR 801 Subpart D) sion Sign-Off

Division of Radiological Devices Office of in Vitro Device Evaluation and Safety

S3000 510(k) Submission

રાભર

{26}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4V1c Phased Array Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeAbdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Pediatric		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567; 063085, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 15 AHP .

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Division of Radiological Devices Office of In itro Diago tic Device Evaluation and Safety 510K

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{27}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6L3 Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Abdominal
IntraoperativeAbdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Pediatric
Small Organ		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,1
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11 15
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Other (specify)

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology Advanced Sieclear spatial compounding Note 11
Note 15 AHP

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Division of Radiological Devic Office of In agnostic Device Evaluation and Sa

510K 5101138

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{28}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

EV8C4 Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 6 7 810
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletaiSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812, K111674

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology 510K

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Division of Radiological Devices

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K121138

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

S3000 510(k) Submission

Page 36 of 59

{29}------------------------------------------------

S3000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

V7M TEE Transducer for use with ACUSON S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify) *	HarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	Note 4
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P	Note 4
Small Organ(specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	Note 4
Trans-esophageal	P	P	P	P	P	P	P	P	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, and #K022567, K093812, K111674

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER, B+CLARIFY VE

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 10 Clarify VE vascular enhancement technology

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

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

SION

{30}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter for use with ACUSON S3000 Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative(Vascular)
Intraoperative(Neurological)
Pediatric		P	P	P	P	P	P		P
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P

P=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812, K111674

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color_ Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

B+M+POWER DOPPLER, B+PWD+POWER.DOPPLER, B+CWD+POWER DOPPLER

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oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Division of Radiological Devices Office of In Device Evalyation and Serie y ਹੈ। ਹੈਲ

S3000 510(k) Submission

{31}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter for use with ACUSON $3000 Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative(Vascular)
Intraoperative(Neurological)
Pediatric		P	P	P	P	P	P		P
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P

P=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812, K111674

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Part 21CFR 801 Subpart D)
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510K

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.