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
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 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 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 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 varis 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
The system transmits ultrasound energy into varis of the body of adult patients creating 2D (B), Color Dopbler (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 or absence 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.

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

This is a 510(k) premarket notification for a predicate device modification. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (ACUSON SC2000™ Diagnostic Ultrasound System, K142628) rather than presenting a new study with explicit acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes.

The document states that the ACUSON SC2000™ Diagnostic Ultrasound System is a "modification to the previously cleared ACUSON SC2000™ Ultrasound System (K142628) and substantially equivalent." It emphasizes that "The ACUSON SC2000™ Diagnostic Ultrasound System is a class II device using the same technology and operating principle as the predicate devices, no clinical data is required." This means that the acceptance criteria are not related to a specific clinical performance study, but rather demonstrate that the modified device maintains the safety and effectiveness of the predicate device.

Therefore, the requested information elements related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, and training set information) are not applicable or explicitly provided in this document as no new clinical study was required or performed for this specific submission.

However, the document does list the technical and regulatory standards that the device adheres to, which effectively serve as its acceptance criteria for non-clinical performance.

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

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Safety - Electrical	AAMI/ANSI 60601-1	Conforms (Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance)
Safety - Electromagnetic	IEC 60601-1-2	Conforms (General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility)
Safety - Ultrasonic	IEC 60601-2-37	Conforms (Particular Requirements For the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and monitoring Equipment)
Usability	IEC 62366	Conforms (Medical Devices Application of Usability)
Software Life Cycle	IEC 62304	Conforms (Medical Device Software Software Life Cycle Processes)
Endoscopic Equipment	IEC 60601-2-18 (if applicable for catheters)	Conforms (Particular Requirements For Basic and Essential Performance of Endoscopic Equipment)
Acoustic Output Display	NEMA UD-3	Conforms (Standard Real-Time Display of Thermal and Mechanical Acoustic Output indices on Diagnostic Ultrasound Equipment)
Acoustic Output Measurement	NEMA UD-2	Conforms (Acoustic Output Measurement Standard for Diagnostic Ultrasound)
Biocompatibility	ISO 10993-1	Conforms (Biological Evaluation of Medical Devices)
Functional Equivalence	Predicate Device (K142628)	Substantially equivalent in intended use, technological characteristics, product codes, transducer types, and modes of operation.

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, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification. The submission relies on non-clinical tests and equivalence to a previously cleared 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, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

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

Not applicable, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

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 a traditional ultrasound system, not an AI-powered device, and no MRMC study was mentioned.

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

Not applicable. This is a traditional ultrasound system, not an AI/algorithm-only device.

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

Not applicable, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

8. The sample size for the training set

Not applicable. This is a traditional ultrasound system, which generally does not involve machine learning "training sets" in the context of diagnostic performance studies for regulatory clearance in the way AI devices do. The testing described is primarily for engineering, safety, and performance standards.

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

Not applicable.

Summary

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

September 6, 2016

SIEMENS MEDICAL SOLUTIONS INC. ULTRASOUND GROUP % Mr. MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET, NW BUFFALO MN 55313

Re: K162221

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: August 4, 2016 Received: August 8, 2016

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,

Robert Oaks

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) K162221

Device Name

Acuson SC2000TM Diagnostic Ultrasound System

Indications for Use (Describe)

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 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 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 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 varis 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

The system transmits ultrasound energy into varis of the body of adult patients creating 2D (B), Color Dopbler (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 or absence 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)

2 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.

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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		P
Abdominal	P	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	P	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P	P		P*	P
Cardiac	P	P	P	P	P	P	P		P*	P	P	P
Trans-esophageal	P	P	P	P	P	P			P*		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P		P*			P
Peripheral Vessel	P	P	P	P	P	P	P	P	P*	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P	P*	P
Other (NeonatalCardiac)	P	P	P	P	P	P	P		P*	P
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P*			P
Other(AbdominalVascular)	P	P	P	P	P	P	P		P*	P

N=new indication. P = Previously Cleared in 510(k) K142628

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):

CW2 Device Name:

Intended Use:

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

ClinicalApplication	CWD	Power(Amplitude)	ColorVelocity	Other:Harmonic
		Doppler	Imaging	Imaging
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) K142628

Additional Comments:

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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) K 142628

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	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	P	P	P	P	P	P	P	P *	P
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) K142628

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) K 142628

Additional Comments:

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510(k) Number (if known):

Device Name:

୧୯.IHD

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
Intraoperative
Pediatric	P	P	P	P	P	P	P	P*	P
Small Organ(specify)	P	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*	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other(AbdominalVascular)	P	P	P	P	P	P	P	P*	P

N=new indication. P = Previously Cleared in 510(k) K142628

Additional Comments:

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510(k) Number (if known):

Device Name:

Z6Ms

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) K 142628

Additional Comments:

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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	A	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	P
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
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) K142628

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:

8V3

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) K142628

Additional Comments:

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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
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) K142628

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) K142628

Additional Comments:

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510(k) Number (if known):

Device Name:

AcuNav 8F and 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 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) K142628

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 142628

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:

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) K142628

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 KongTitle: Regulatory Affairs SpecialistTelephone: (650) 969-9112
Submission Date:	July 20, 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

The ACUSON SC2000™ Ultrasound System in this 510(k) is a modification to the previously cleared ACUSON SC2000™ Ultrasound System (K142628) and substantially equivalent.

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

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 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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Substantial Equivalence

The submission device is a modification to ACUSON SC2000™ Diagnostic Ultrasound System as previously cleared in K142628. With regard to both intended use and technological characteristics, the modified device is substantially equivalent to the previously cleared device (K142628).

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System Substantial Equivalence Table

Description	Acuson SC2000™ K142628	Acuson SC2000™This submission
Indications for Use	The SC2000 ultrasound imaging 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-skeletalSuperficial applications. The system also provides the ability to measure anatomical structuresand calculation packages that provide information to the clinician that may be used adjunctivelywith other medical data obtained by a physician for clinical diagnosis purposes. The typicalexaminations performed using the SC2000 Ultrasound System are:	Same
	Cardiac Imaging Applications and Analysis
	The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiacpatients 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 bloodflow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structuresto evaluate the presence or absence of pathology. The system may be used to acquire patientelectrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.The system also supports catheters which are intended for intra-cardiac and intraluminalvisualization of cardiac and great vessel anatomy and physiology as well as visualization ofother devices in the heart of adult and pediatric patients.The system has Cardiac Measurements and Calculation Packages that provide informationthat may be used adjunctively with other medical data obtained by a physician for clinicaldiagnosis purposes.
	Vascular Imaging Applications and Analysis
	The system transmits ultrasound energy into various parts of the body of adult patients creating2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), andContinuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotidarteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and
Description	Acuson SC2000™ K142628	Acuson SC2000™
		This submission
	legs and abdomen; and surrounding anatomical structures to evaluate the presence orabsence of pathology. The system may be used to acquire patient electrocardiogram forsynchronizing the diastolic and systolic capture of ultrasound images.
	The system has Vascular Measurements and Calculation Packages that provide informationthat may be used adjunctively with other medical data obtained by a physician for clinicaldiagnosis purposes.
	Superficial Imaging Applications
	The system transmits ultrasound energy into various parts of the body of adult patients creating2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), andContinuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional orsuperficial musculoskeletal structures and surrounding anatomical structures to evaluate thepresence or absence of pathology. The system may be used to acquire patientelectrocardiogram 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 creating2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) toobtain 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), andContinuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain andsurrounding anatomical structures to evaluate the presence or absence of pathology.
	The system provides Measurement Packages that provide information that may be usedadjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Description	Acuson SC2000™ K142628	Acuson SC2000™This submission
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)-Continuos Doppler Mode (CWD)-Color Doppler Mode-Amplitude Doppler Mode-Color Velocity Imaging-3D Imaging-4D Imaging	Same
Description	Acuson SC2000™ K142628	Acuson SC2000™This submission
Imaging
Multi-Hertz multiple frequencyimaging	×	Same
Output display standardcompliance	×	Same
Dual screen	×	Same
Acoustic clip capture	×	Same
Cardiac Measurements andCalculations	×	Same
DTI™ Doppler tissue imaging	×	Same
Contrast Imaging
Contrast pulse sequencingtechnology (CPS)	×	Same
TEQ and NTEQ ultrasoundtechnology for CPS	×	Same
Vascular Imaging
Vascular Calculation andMeasurements	×	Same
Spatial Compounding	×	Same
Semi Auto Doppler Option(Trace Assist)	×	Same
Transcranial Imaging	×	Same
Connectivity
Wireless NetworkConnectivity	×	Same
DICOM Compatibility	×	Same

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A brief discussion of the non-clinical test submitted, referenced, or relied on in the special 510(k) for determination of substantial equivalence.

The devices have 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 the applicable medical device safety standards. The systems comply 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 - Collateral Standard Electromagnetic Compatibility
IEC 60601-2-37 Medical Electrical Equipment Part 2-37: Particular . Requirements For the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and monitoring Equipment
IEC 62366 Medical Devices Application of Usability .
IEC 62304 Medical Device Software Software Life Cycle Processes .
IEC 60601-2-18 Medical Electrical Equipment Part 2-18 Particular . Requirements For Basic and Essential Performance of Endoscopic Equipment
. NEMA UD-3 Standard Real-Time Display of Thermal and Mechanical Acoustic Output indices on Diagnostic Ultrasound Equipment
NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound
. 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 SC2000™ Diagnostic Ultrasound System is a class II device using the same technology and operating principle as the predicate devices, no clinical data is required.

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Conclusion

As shown by the substantial equivalence table above, the modified ACUSON SC2000™ Diagnostic Ultrasound System is substantially equivalent as the predicate ACUSON SC2000™ Diagnostic Ultrasound System (K142628).

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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.