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-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, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

Device Description

The 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 text describes a 510(k) premarket notification for the Siemens Acuson SC2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K132654) due to modifications. The document does not describe an AI or algorithm-based device or a study involving an algorithm's performance.

Therefore, many of the requested categories (acceptance criteria for an algorithm, AI performance, MRMC study, training set information, ground truth methods for an algorithm) cannot be extracted or are not applicable to the provided content.

The information primarily concerns the intended uses and technical characteristics of an ultrasound system and its transducers, demonstrating that new components (like the Z6Ms transducer) and updated catheters still fall within the scope of the predicate device.

However, based on the general principles of medical device 510(k) submissions, I can infer what "acceptance criteria" and "study" would generally mean in this context for a non-AI ultrasound device, and extract relevant performance information.

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

For a standard diagnostic ultrasound system like the Acuson SC2000™, the "acceptance criteria" are intrinsically tied to meeting established safety and performance standards for ultrasound devices, as well as demonstrating that the device performs as intended for its specified clinical applications. The "reported device performance" refers to the results of testing confirming compliance with these standards and the functionality for the intended uses.

Acceptance Criteria Category	Specific Criteria (Inferred from documentation)	Reported Device Performance (Inferred from documentation)
Safety Standards Compliance	Device must comply with all applicable safety standards (electrical, mechanical, acoustic output, biocompatibility).	The Acuson SC2000™ has been designed to meet and has been subjected to extensive safety and performance testing ensuring compliance with: - AIUM/NEMA UD-3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)- AIUM/NEMA UD-2 (Acoustic Output Measurement Standard)- IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance)- IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)- IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)- IEC 62304 (Medical device software – Software life cycle processes)- IEC 62366 (Medical devices – Application of usability engineering to medical devices)- ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
Intended Use Functionality	The system and its transducers must reliably perform imaging and measurement functions for specified clinical applications (e.g., Cardiac, Pediatric, Fetal, Abdominal, Vascular, Intraoperative, Transcranial, Musculoskeletal).	The system creates 2D(B), 3D, M-Mode, Color Doppler, Color Power Doppler, Pulsed Wave Doppler, and Continuous Wave Doppler images/data to obtain images and blood flow velocity, enabling evaluation of pathology and provision of measurement/calculation packages for diagnostic purposes across all stated applications. The system supports various transducers (e.g., V5Ms, 4Z1c, Z6Ms, CW2, 4V1c, 6CIHD, 8V3, 9L4, 10V4, AcuNav 8F/10F, AcuNav V 10F, SoundStar 10F) for these applications.
Technological Characteristics	Key characteristics (e.g., array type, dimensional imaging, mechanical controls, modes of operation, multi-Hertz imaging, output display, dual screen, acoustic clip capture, Cardiac/Vascular measurements, DTI, Contrast Imaging, Connectivity via Wireless/DICOM) must be maintained or be substantially equivalent to the predicate device.	The system maintains similarity in product codes, transducer types, modes of operation, multi-Hertz multiple frequency imaging, output display standard compliance, dual screen functionality, acoustic clip capture, Cardiac/Vascular Measurements and Calculations, DTI™, Contrast Pulse Sequencing Technology (CPS), TEQ and NTEQ ultrasound technology, Spatial Compounding, Semi Auto Doppler Option (Trace Assist), Transcranial Imaging, and connectivity features (Wireless Network Connectivity, DICOM Compatibility) as compared to the predicate K132654. The new Z6Ms transducer's array type, dimensional imaging, and mechanical controls are deemed substantially equivalent to existing transducers (4Z1c and V5Ms).

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 does not directly specify a "test set" in the context of an algorithm or diagnostic performance study with patient data. For a non-AI ultrasound system like this, compliance is typically demonstrated through:

Engineering verification and validation (testing of components, software, and integrated system against specifications).
Bench testing for acoustic output and electrical safety.
Potentially, limited clinical evaluations or comparisons to the predicate device to confirm imaging quality and diagnostic utility for the new or modified components.

The submission states, "Final testing of the SC2000™ included various safety and performance testing designed to ensure the device meets all of its specifications." However, no specific sample size (e.g., number of patients or images) for a clinical "test set" is provided, nor is the data provenance explicitly stated. This information is typically proprietary to the manufacturer and not fully disclosed in the 510(k) summary, especially for devices establishing substantial equivalence through technical modifications rather than new clinical claims requiring large-scale trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Again, this document does not describe an AI or algorithm-based device that would require a ground truth established by experts for a test set. For a diagnostic ultrasound system, "ground truth" for demonstrating diagnostic utility would typically involve comparison to other established diagnostic modalities or expert clinical interpretation. However, the document does not provide details on such a study for "ground truth" establishment.

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

Not applicable, as no external "test set" requiring expert adjudication is described for an AI algorithm.

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, as the document concerns a medical imaging device (ultrasound system and transducers), not an AI algorithm intended to assist human readers.

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

Not applicable, as the device is not an AI algorithm.

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

Not explicitly stated for the purpose of validating the diagnostic accuracy of the ultrasound system in a formal study. For an ultrasound device, diagnostic accuracy is often evaluated relative to established clinical standards, other imaging modalities, or direct observation (e.g., during surgery or pathology). However, the submission focuses on demonstrating safety, technical performance, and substantial equivalence to a predicate device, rather than providing details of a de novo diagnostic accuracy trial with a specific "ground truth."

8. The sample size for the training set

Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm that undergoes "training."

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

Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm.

Summary

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

October 10, 2014

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

Re: K142628

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: September 11, 2014 Received: September 16, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson SC2000 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

CW2 V5Ms V7M 10V4 AcuNav V 10F 4Z1c 6CIHD 8V3 AcuNav 8F SoundStar 10F

4V1c Z6Ms 9L4 AcuNav 10F

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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.

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,

Sm.f)

for

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

Enclosure

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Page 3—Mr. Job

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Indications for Use

510(k) Number (if known)

K142628

Device Name

Acuson SC2000™ Diagnostic Ultrasound System

Indications for Use (Describe)

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-sketal 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 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 deep veins 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 yelocity 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 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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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	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
Musculo-skeletalSuperficial	P	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) K132654

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

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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) K132654

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	A	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:HarmonicImaging	Other:RealTime3D
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 (specify)

N=new indication. P = Previously Cleared in 510(k) K132654

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) K132654

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	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other:3D
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	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) K132654

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) K132654

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

N=new indication. P = Previously Cleared

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
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) K132654

Additional Comments:

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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) K132654

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	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
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P*	P
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K132654

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) K132654

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	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify)
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
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) K132654

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) K132654

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) K132654

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 Division
	685 East Middlefield Road
	Mountain View, California 94043

Contact Person: Primary Contact: Kevin Kong, RAC Telephone: (650) 969-9112

Secondary Contact:

Robert F. Lawrence Telephone: (650) 969-9112

Submission Date: Aug 6, 2014
Acuson SC2000™ Diagnostic Ultrasound System Device Name:
Common Name: Diagnostic Ultrasound System
Classification: Regulatory Class: ll

Review Category: Tier II Classification 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 ●

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Diagnostic Ultrasound Transducer

. 21 CFR # 892.1570
. Product Code ITX

Diagnostic Intravascular Catheter

. 21 CFR # 870.1200
Product Code OBJ .

Legally Marketed Predicate Devices

The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K132654.

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

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.

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Substantial Equivalence

The submission device is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K132654 with regard to both intended use and technological characteristics.

Transducer Substantial Equivalence Table

Description	Acuson SC2000™ K132654(V5Ms, 4Z1c Transducers)	Acuson SC2000™ Thissubmission (Z6MsTransducer)
Application	V5Ms: Pediatric, Cardiac,Transesophageal4Z1c:Fetal Pediatric, Cardiac	Cardiac,Transesophageal
Array Type	V5Ms: Phased Array4Z1c: 2D Matrix Array	Same as 4Z1c
Dimensional Imaging	V5Ms: 2D Image4Z1c: 3D Image	Same as 4Z1c
Mechanical Controls forArticulation	V5Ms: Mechanical4Z1c: N/A No Mechanicalcontrols	Same as V5Ms
Tip Articulation Range	V5Ms:Anterior: 120 degreesPosterior: 90 degreesLeft/Right: +/- 45 degrees4Z1c: N/A No Mechanicalcontrols	Anterior: 120 degreesPosterior:60 degreesLeft/Right: +/-45 degrees
Description	Acuson SC2000™ K132654	Acuson SC2000™ Thissubmission
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
Imaging
Multi-Hertz multiple frequencyimaging	X	Same
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
Description	Acuson SC2000™ K132654	Acuson SC2000™ This submission
Contrast Imaging
Contrast pulse sequencing technology (CPS)	X	Same
TEQ and NTEQ ultrasound technology for CPS	X	Same
Vascular Imaging
Vascular Calculation and Measurements	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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SC2000™ System Substantial Equivalence Table

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Performance Data

The SC2000™ is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the SC2000™ included various safety and performance testing designed to ensure the device meets all of its specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards including:

The Acuson SC2000™ has been designed to meet the following product acoustic output, biocompatibility, thermal, electromagnetic and mechanical safety standards:

. AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
. Safety and EMC Requirements for Medical Equipment
- IEC 60601-1 .
- . IEC 60601-1-2
- . IEC 60601-2-37

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י IEC 62304
IEC 62366 .
ISO 10993-1 .

Conclusion

As shown by the substantial equivalence table above, the modified Acuson SC2000™ is substantially equivalent as the predicate Acuson SC2000™ K132654

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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.