The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis
Vascular Imaging Applications and Analysis
Superficial Imaging Applications
Intraoperative Imaging Applications
Transcranial Imaging Applications

Device Description

The ACUSON SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system, 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 the following modes (The following modes below can be operated in combination or individually):

B-Mode
M-Mode .
Pulsed (PWD) Doppler Mode .
Continuous (CWD) Doppler Mode
Color Doppler Mode .
Amplitude Doppler Mode
Color Velocity Imaging .
3D Imaging,
4D Imaging (3D imaging in real time) .

AI/ML Overview

The provided document is a 510(k) premarket notification for the Siemens ACUSON SC2000™ Diagnostic Ultrasound System (K170315). It primarily details the device's indications for use and asserts substantial equivalence to a previously cleared predicate device (K162221). The document states that clinical data was NOT required for substantial equivalence, as the device is a Class II device and uses the same technology and operating principles as the predicate.

Therefore, the submission does not include any studies proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy in a clinical context. The review focuses on technical parameters, safety, and equivalence to a predicate.

However, based on the information provided, I can infer the implied acceptance criteria through compliance with standards and the "Substantial Equivalence Table" (page 22).

Here's a breakdown of the requested information based on the provided text, recognizing the absence of clinical performance studies:

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

Since no clinical performance metrics are reported, the "acceptance criteria" here are implied by the safety and technical standards compliance and the "Same" performance claims against the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with AAMI/ANSI 60601-1 (Basic Safety & Essential Performance)	Conforms with standard
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Conforms with standard
Compliance with IEC 60601-2-37 (Ultrasonic Medical Diagnostic Monitoring)	Conforms with standard
Compliance with IEC 62366 (Application of Usability)	Conforms with standard
Compliance with IEC 62304 (Medical Device Software Life Cycle Process)	Conforms with standard
Compliance with NEMA UD-2 (Acoustic Output Measurement Standard)	Conforms with standard
Compliance with NEMA UD-3 (Real-Time Display of Thermal and Mechanical Acoustic Output Indices)	Conforms with standard
Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices)	Conforms with standard
Acoustic Output	Evaluated, complies with standards
Biocompatibility	Evaluated, complies with standards
Cleaning and Disinfection Effectiveness	Evaluated, complies with standards
Thermal Safety	Evaluated, complies with standards
Electromagnetic Safety	Evaluated, complies with standards
Mechanical Safety	Evaluated, complies with standards
Product Code(s) (IYO, IYN, ITX, OBJ)	Same as predicate (K162221)
Transducer Types (Matrix Array, Phased Array, Linear Array, Curved Array)	Same as predicate (K162221)
Modes of Operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, 3D, 4D)	Same as predicate (K162221)
Multi-Hertz multiple frequency imaging	Same as predicate (K162221)
Output display standard compliance	Same as predicate (K162221)
Dual screen	Same as predicate (K162221)
Acoustic clip capture	Same as predicate (K162221)
Cardiac Measurements and Calculations	Same as predicate (K162221)
DTI™ Doppler tissue imaging	Same as predicate (K162221)
Contrast pulse sequencing technology (CPS)	Same as predicate (K162221)
TEQ and NTEQ ultrasound technology for CPS	Same as predicate (K162221)
Vascular Imaging (Calculation and Measurements)	Same as predicate (K162221)
Spatial Compounding	Same as predicate (K162221)
Semi Auto Doppler Option (Trace Assist)	Same as predicate (K162221)
Transcranial Imaging	Same as predicate (K162221)
Wireless Network Connectivity	Same as predicate (K162221)
DICOM Compatibility	Same as predicate (K162221)

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

Not applicable. The document explicitly states that "clinical data is not required for substantial equivalence" (page 24). The evaluation was based on non-clinical tests (acoustic output, biocompatibility, cleaning, thermal, electromagnetic, and mechanical safety) and comparison to a predicate device.

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)

Not applicable. No clinical test set or expert-established ground truth is mentioned. The assessment was based on engineering and safety standards.

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

Not applicable. No clinical test set.

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

Not applicable. This is not an AI/CADe device, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is a diagnostic ultrasound system, not an algorithm, and no standalone performance study is mentioned.

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

Not applicable. For the determination of substantial equivalence, the "ground truth" was compliance with established medical device safety and performance standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993-1) and the technical specifications of the predicate device (K162221).

8. The sample size for the training set

Not applicable. No algorithms requiring a training set are discussed in the context of this 510(k) submission.

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

Not applicable. No algorithms requiring a training set are discussed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by a flowing line. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

April 4, 2017

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

Re: K170315

Trade/Device Name: Acuson SC2000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: March 27, 2017 Received: March 28, 2017

Dear Mr. Job:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

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

Enclosure

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Indications for Use

510(k) Number (if known)

K170315

Device Name

Acuson SC2000TM Diagnostic Ultrasound System

Indications for Use (Describe)

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediativ, neonatal, and fetal cardiac patients creating 2D (B). 3D. M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intended for 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. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively

with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Number (if known):

Device Name: SC2000 Diagnostic Ultrasound System

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging	Other:3D	Other:RealTime3D
Ophthalmic
Fetal		P	P	P	P	P	P		P*	P		P
Abdominal		P	P	P	P	P	P		P *	P	P
IntraoperativeAbdominal		P	P	P	P	P	P		P *	P
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		P*	P	P	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic		P	P	P	P	P	P		P*	P
Cardiac		P	P	P	P	P	P		P*	P	P	P
Trans-esophageal		P	P	P	P	P			P*		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P		P*			P
Peripheral Vessel		P	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P*	P
Musculo-skeletalSuperficial		P	P	P .		P	P	P	P*	P
Other (NeonatalCardiac)		P	P	P	P	P	P		P*	P
Other (Intra-Cardiac)	ਿ	P	P	P	P	P	P		P*			P
Other(AbdominalVascular)		P	P	P	P	P	P		P*	P

N=new indication. P = Previously Cleared in 510(k) K162221

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

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

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510(k) Number (if known):

Device Name: CW2

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric					P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel					P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. Previously Cleared in 510(k) K162221

Additional Comments: 11

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510(k) Number (if known):

Device Name:

4Z1c

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
Ophthalmic
Fetal	P	P	P	P	P	P*	P	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P*	P	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P*	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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510(k) Number (if known):

Device Name:

4V1c

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P*	P
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K16221

Additional Comments:

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510(k) Number (if known):

Device Name:

V5Ms

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P
Trans-esophageal	P	P	P	P	P	P	P*	P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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510(k) Number (if known):

Device Name:

6C1HD

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P*	P
Intraoperative
Pediatric	P	P	P	P	P	P	P*	P
Small Organ(specify)	P	P	P	P	P	P	P*	P
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(AbdominalVascular)	P	P	P	P	P	P	P*	P

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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510(k) Number (if known):

Device Name:

Z6Ms

网

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P*	P	P
Trans-esophageal	P	P	P	P	P	P	P*	P	P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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

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510(k) Number (if known):

Device Name:

V7M

Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging	Other:3D
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P*	P	P
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P		P*		P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P		P*		P
Trans-esophageal	P	P	P	P	P		P*		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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

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8V3

510(k) Number (if known):

Device Name:

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P *	P
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P *	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P *	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K16221

Additional Comments:

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

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510(k) Number (if known):

Device Name:

9L4

Indications for Use:

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

ClinicalApplication	A	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel	P	P	P	P	P	P	P	P*	P
Laparoscopic	P	P	P	P	P	P	P		P
Musculo-skeletalConventional	P	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P*	P
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K162221

Additional Comments:

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510(k) Number (if known):

· Device Name:

10V4

Intended Use:

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

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:HarmonicImaging
Ophthalmic
Fetal	P	P	P	P	P	P	P	P*	P
Abdominal	P	P	P	P	P	P	P	P*	P
IntraoperativeAbdominal	P	P	P	P	P	P	P	P*	P
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (NeonatalCardiac)	P	P	P	P	P	P	P	P*	P

N=new indication. Previously Cleared in 510(k) K162221

Additional Comments:

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510(k) Number (if known):

Device Name:

Intended Use:

AcuNav 8F and 10F Ultrasound Catheter

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 as follows:

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P*
Small Organ(specify) **
NeonatalCephalic
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*

N=new indication. P = Previously Cleared in 510(k) K 162221

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

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510(k) Number (if known):

Device Name:

Intended Use:

ACUSON AcuNav™ V 10F Ultrasound Catheter

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)	Other:RealTime3D
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	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*	P

N=new indication. P = Previously Cleared in 510(k) K 162221

Additional Comments:

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510(k) Number (if known):

Device Name:

SoundStar 10F Ultrasound Catheter

Intended Use:

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:

a a

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(specify) **
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	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*

N=new indication. P = Previously Cleared in 510(k) K 162221

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

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510(k) Summary

Sponsor:	Siemens Medical Solutions, Inc.Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Kevin Kong, RACTitle: Regulatory Affairs SpecialistTelephone: (650) 969-9112
Submission Date:	December 19, 2016
Device Name:	ACUSON SC2000™ Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System
Classification:	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, Radiology

Ultrasonic Pulsed Doppler Imaging System

21 CFR # 892.1550 .
Product Code IYN .

Ultrasonic Pulsed Echo Imaging System

21 CFR # 892.1560 .
Product Code IYO .

Diagnostic Ultrasound Transducer

21 CFR # 892.1570 ●
Product Code ITX .

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Diagnostic Intravascular Catheter

. 21 CFR # 870.1200
. Product Code OBJ

Legally Marketed Predicate Devices

Device Name	510(k)
ACUSON SC2000™ Diagnostic Ultrasound System	K162221

Device Description:

B-Mode
M-Mode .
Pulsed (PWD) Doppler Mode .
Continuous (CWD) Doppler Mode
Color Doppler Mode .
Amplitude Doppler Mode
Color Velocity Imaging .
3D Imaging,
4D Imaging (3D imaging in real time) .

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Intended Use

The ACUSON SC2000™ Diagnostic Ultrasound System is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are 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.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

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The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

Transcranial Imaging Applications

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

SIEMENS

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Substantial Equivalence

The submission device is a modification to ACUSON SC2000™ Diagnostic Ultrasound System. The modified device is substantially equivalent to the ACUSON SC2000™ Diagnostic Ultrasound System as previously cleared in K162221.

Substantial Equivalence Table

Description	ACUSON SC2000™K162221	This Submission:ACUSON SC2000™
Product Code(s)	System: IYO, IYNTransducers: ITXIntravascular Catheter: OBJ	Same
Transducer Types	-Matrix Array-Phased Array-Linear Array-Curved Array	Same
Modes of Operation	-B Mode-M Mode-Pulse Wave Doppler Mode(PWD Mode)-Continuous Doppler Mode(CWD)-Color Doppler Mode-Amplitude Doppler Mode-Color Velocity Imaging-3D Imaging-4D Imaging	Same
Imaging
Multi-Hertz multiple frequencyimaging	X	Same
Description	ACUSON SC2000™K162221	This Submission:ACUSON SC2000™
Output display standardcompliance	X	Same
Dual screen	X	Same
Acoustic clip capture	X	Same
Cardiac Measurements andCalculations	X	Same
DTI™ Doppler tissue imaging	X	Same
Contrast Imaging
Contrast pulse sequencingtechnology (CPS)	X	Same
TEQ and NTEQ ultrasoundtechnology for CPS	X	Same
Vascular Imaging
Vascular Calculation andMeasurements	X	Same
Spatial Compounding	X	Same
Semi Auto Doppler Option(Trace Assist)	X	Same
Transcranial Imaging	X	Same
Connectivity
Wireless Network Connectivity	X	Same
DICOM Compatibility	X	Same

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Siemens Medical Solutions, Inc. Ultrasound Division

SIEMENS

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Non-clinical Tests submitted, referenced, or relied on for determination of substantial equivalence

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

. AAMI/ANSI 60601-1: Medical Electrical Equipment – Part 1 General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance: Electromagnetic Compatibility
IEC 60601-2-37: Medical Electrical Equipment Part 2-37 For Basic Safety and . Essential Performance of Ultrasonic Medical Diagnostic Monitoring Equipment
IEC 62366: Medical Devices Application of Usability ●
IEC 62304: Medical Device Software Software Life Cycle Process ●
NEMA UD-2: Acoustic Output Measurement Standard for Diagnostic Ultrasound .
NEMA UD-3: Standard for Real-Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
. ISO 10993-1: Biological Evaluation of Medical Devices

Summary discussion of the clinical tests submitted, referenced, or relied on for determination of substantial equivalence

The ACUSON Freestyle™ Ultrasound System is a class II device, and uses the same technology and operating principle as the predicate devices; clinical data is not required for substantial equivalence.

Conclusion

As shown by the substantial equivalence tables above, the modified ACUSON SC2000™ Diagnostic Ultrasound System is substantially equivalent as the predicate ACUSON SC2000™ Diagnostic Ultrasound System (K162221).

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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.