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 B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode. Color Doppler Mode. Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

AI/ML Overview

The provided 510(k) summary for the Siemens SC2000 Ultrasound System focuses on demonstrating substantial equivalence to previously cleared devices rather than outlining detailed acceptance criteria and a specific study proving device performance against those criteria. The submission is for a modification to an existing device (SC2000 Diagnostic Ultrasound System) and a new feature (Clarify VE).

Therefore, this document does not contain the specific information requested about acceptance criteria and a study demonstrating performance against them in the way a submission for a novel AI device might. Instead, it relies on demonstrating that the modified device continues to meet existing safety and performance standards, and that the new feature is substantially equivalent to a feature already cleared on another Siemens device.

However, I can extract information related to the performance data and the comparison to predicate devices, which implicitly serves as the "proof" of meeting acceptance criteria for a substantial equivalence determination.

Here's the breakdown of the requested information based on the provided text, along with notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity targets) for a new algorithm or feature in the way a novel AI medical device submission would. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with established safety and performance standards and showing substantial equivalence to predicate devices.

The "reported device performance" is described qualitatively as meeting these standards and having similar technological characteristics and intended uses as cleared predicates.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety Compliance (e.g., UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 60601-1-1, IEC 60601-1-2, IEC 1157, ISO 10993-1)	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. Final testing ensured the device meets all specifications and complies with applicable industry and safety standards listed (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 1157, ISO 10993-1).
Functional Equivalence - Intended Use (across various applications like Cardiac, Vascular, Superficial, Intraoperative, Transcranial)	The SC2000 ultrasound imaging system's intended uses are consistent with previous clearances (K072365, K102017, K113179, K123622, K130754) and traditional clinical practice. The detailed intended use descriptions for the overall system and specific transducers (e.g., 9L4, 6C1HD, V5M, 4V1c, 8V3, CW2, 4Z1c, AcuNav 8F/10F, AcuNav V, SoundStar 10F, 10V4, V7M) are listed as "P = Previously Cleared" indicating they meet previously established use cases.
Functional Equivalence - Technological Characteristics (e.g., imaging modes, features like Clarify VE, accessories, transducers, workflow acceleration, calculations packages)	The modified device has substantially equivalent indications for use and technological characteristics as the predicate devices ACUSON S2000 (K111674, 072786) and ACUSON SC2000 (K113179). The new feature, Clarify VE, is stated to be the same feature used on the S2000 (K072786) and described as "enhancing Bmode tissue resolution and reducing acoustic clutter... provides clearer vessel wall definition, improves tissue boundary detection and tissue contrast resolution, while preserving spatial resolution." The new 6C1HD transducer also has "no differences... from its use in S2000." The extensive comparison table (Section D) shows that almost all features were present in predicate devices ("X" under previous 510(k)s).
Quality System Compliance	The design and development process conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards.

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

This information is not provided in the document. The submission focuses on substantial equivalence based on prior clearances and the nature of the modifications (Clarify VE being identical to a previously cleared feature on another system, and the new transducer being similar to existing ones). There is no mention of a specific clinical test set for this 510(k) submission.

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)

This information is not provided as there is no specific clinical test set described in this 510(k) summary for establishing ground truth for a novel AI algorithm. The device is an ultrasound system with enhanced imaging features, not an AI diagnostic algorithm requiring expert-labeled ground truth for evaluation in this context.

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

This information is not provided for the same reasons as point 3.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study would typically be performed for new AI-powered diagnostic aids, which is not the primary focus of this 510(k) submission (which is for a modification to an existing ultrasound system including a feature like Clarify VE, which enhances image quality rather than providing a direct diagnostic output that would assist human readers in a comparative effectiveness study).

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

This is not applicable and not mentioned. The device described is an ultrasound system, not a standalone algorithm. Clarify VE is an image enhancement feature integrated into the system, not a standalone algorithm output.

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

This information is not provided for a test set, as no specific clinical test set for new feature evaluation is detailed. The "performance data" section focuses on engineering verification and validation against safety and performance standards for the ultrasound system itself, not the clinical accuracy of a diagnostic output.

8. The sample size for the training set

This information is not provided. The document describes an ultrasound imaging system with a new image enhancement feature, not a machine learning model that would have a distinct training set.

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

This information is not provided for the same reasons as point 8.

Summary

{0}------------------------------------------------

SC2000 Ultrasound System 510(k) Submission

Siemens Medical Solutions. Inc. Ultrasound Division

510(k) Summary Prepared July 26, 2013

Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
----------	-------------------------------------------------------------------------------------------------------------------------

Contact Person: Patrick J. Lynch (650) 694-5658 Telephone: (650) 694-5580 Fax:

July 26, 2013 Submission Date:

Acuson SC2000™ Diagnostic Ultrasound System Device Name:

Common Name: Diagnostic Ultrasound System

Classification:

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

Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer Diagnostic Intravascular Catheter

FR # 892.1560 FR # 892.1570 FR # 870.1200

Product Code 90-IYN Product Code 90-IYO Product Code 90-1TX Product Code OBJ

A. Legally Marketed Predicate Devices

The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365, K102017, K113179, K123622 and K130754.

B. Device Description:

The SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP)

SC2000 510(k) Submission

{1}------------------------------------------------

C. 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, cardlac 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 intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physlology 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 uttrasound 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 analomical 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 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 dlastolic 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.

{2}------------------------------------------------

D. Substantial Equivalence

The submission device is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365, K072786, K102017, K113179, K123622 and K130754 with regard to both intended use and technological characteristics.

Description	AcusonSC2000™K123622	AcusonS2000K111674	AcusonS2000K072786	AcusonSC2000™Thissubmission
System
Hardware Safety - EN60601-1 Certified	X	X	X	X
Software Safety - EN60601-4 Certified	X	X	X	X
Acoustic Thermal Safety - EN60601-2-37 Certified	X	X	X	X
Transducers
See Table in Section 4.4.1.4 - All previously cleared	X	X	X	X
Biocompatibility - Same transducers no new materials	X	X	X	X
6C1HD Transducer	X	X	X	X
AcuNav 8F/10F	X	X	X	X
AcuNav V	X	X	X	X
Soundstar 10F	X	X	X	X
Biocompatibility - Same transducers no new materials	X	X	X	X
Accessories
Respirometer	X	X	X	X
AcuNav Joystick	X	X	X	X
Imaging
SpaceTime™ resolution control	X	X	X	X
Native™ Tissue Harmonic Imaging	X	X	X	X
MultiHertz multiple frequency imaging	X	X	X	X
REST™ enhanced resolution imaging format	X	X	X	X
Output display standard compliance	X	X	X	X
Native TEQ™ dynamic ultrasound technology	X	X	X	X
TEQ™ ultrasound technology	X	X	X	X
TEQ™ technology for Spectral PW and CW Doppler	X	X	X	X
Dual screen and live dual imaging	X	X	X	X
Acoustic clip capture	X	X	X	X
eSie Measure Workflow Acceleration	X	X	X	X
Preset functionality with preset ordering and groupingcapabilities and linking to MultiHertz™ multiple frequencyImaging	X	X	X	X
Integrated Stress echo capability	X	X	X	X

SC2000 510(k) Submission

ﻢ ﻣ

{3}------------------------------------------------

Siemens Medical Solutions, Inc. Ultrasound Division

SC2000 Ultrasound System

DTI™ Doppler tissue imaging includes the following colorDoppler capabilities:	x	x	X	X
DTI Velocity (DTV)	X	X	X	X
Color Doppier Harmonic capability in DTI	x	. X	X	X
High Frame Rate Tissue Doppler (HTD) Capability	×	X	×	×
DTI Energy (DTE)	x	X	x	×
	X	×	x	X
Color Doppler Velocity (CDV)	×	x	X	X
Color Harmonic imaging	X	×	×	X
DTI Pulsed Wave (DTI PW) capability	X	×	X	X
Color Doppler M-Mode for:	×		X	X
CDV		X		X
DTV	xX	×X	×X	X
DIEContrastimaginal program of the state of the states	and and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution o	,ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ	200	No. of
		X	X	x
Cadence™ contrast pulse sequencing technology (CPS)PrecisonBurst programmable triggering for contrast agent	×
destruction	X	X	×	X
TEQ and NTEQ ultrasound technology for Cadence™ CPS	×	×	×	X
Cardiac Calculations & Salations & Sales Callery Cardination	an and the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the provincial of the p	新闻网 - 国际	,在线上	,
Cardiac calculations package	×			X
Slope Line calculations	X			X
Generic Calculations/Ratio function	×			X
avascular imaging package direct on	,ક વિદ્યાર		155 - 1	,如此时
B-mode, M-mode, NTHI, CPS, PW Doppler, Triplex imagingand High Resolution Color Flow (HRCF)	X	X	x	X
Cadence™ CPS Capture	x	X	X	×
Advanced SieClear™ spatial compounding with Dynamic TCETM (tissue contrast enhancement) technology	×	X	×	×
Advanced Vascular Analysis report package	X	X	×	×
Clarify™ Vascular Enhancement Technology		ਮ	×	×
Linear and Vector imaging formals	X	X	×	×
Auto Doppler option	×	×	×	X
Time averaged velocity (TAV) calculation	x	X	x	X
Vascular Calculation package	X	×	×	X
Transcranial imaging	×	×	×	X
Cation packages - Marie	のお店	19751999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -		19731 - 1 - 1 4 -
syngo® Mitral Valve Assessment	X	x	×	×
syngo® auto Ejaction Fraction technology	X	X	×	X
D1ART with syngo® fourSight™ TEE view	X	x	x	X
syngo® Quantitative Synch Tools™ technology (QST)	×	×	X	X
syngo® Velocity Vector Imaging™ technology (VVI) rotation	X	×	×	×
syngo® ACQ auto-tracking contrast quantification	X	×	×	×

SC2000 510(k) Submission

Page 10 of 32

{4}------------------------------------------------

·Siemens Medical Solutions, Inc. Ultrasound Division

SC2000 Ultrasound System 510(k) Submission

Wireless Network Connectivity	X			X
DICOM Print Service	X	X	X	X
DICOM Media Storage Service	X	X	X	X
DICOM Structured Reporting	X	X	X	X

Technological Comparison

The new feature, Clarify VE, or Clarify is the same feature used on the S2000 (K072786). Clarify vascular enhancement technology uses power flow information to enhance Bmode tissue resolution and reduce acoustic clutter throughout the region of interest. Clarify also provides clearer vessel wall definition, improves tissue boundary detection and tissue contrast resolution, while preserving spatial resolution.

Similarities

As can be seen from the comparison table and the device description above, the modified device has substantially equivalent indications for use and technological characteristics as the predicate devices ACUSON $2000 (K111674, 072786) and ACUSON SC2000 (K113179)

Differences

There are no differences for the new transducer (6C1HD) and feature (Clarify VE) from its use in S2000.

SC2000 510(k) Submission

Page 11 of 32

{5}------------------------------------------------

K132654
Page 6 of 6

SC2000 Ultrasound System 510(k) Submission

E. 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 safety standards:

UL 60601-1, Safety Requirements for Medical Equipment ■
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment I
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 60601-1-1 .
- IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power 세
ISO 10993-1 Biocompatibility 해

F. Summarv

Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the SC2000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

SC2000 510(k) Submission

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

Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle, with three lines forming the body and wings. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 26, 2013

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

Re: K132654

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 and OBJ Dated: August 21, 2013 Received: September 4, 2013

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: CDRFI docs 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 System, as described in your premarket notification:

Transducer Model Numbers

9L4	6C1I:ID	V5M
4V1c	8V3	CW2
4Z1c	V7M	10V4

AcuNay 8F and 10F Ultrasound Catheter ACUSON AcuNay™ V 10F Ultrasound Catheter SoundStar 10F Ultrasound Catheter

{7}------------------------------------------------

Page 2-Mr. Job

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara.

for

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

Enclosure

{8}------------------------------------------------

510(k) Number (if known): K132654

Device Name:

SC2000™ Diagnostic Ultrasound System

Indications for Use:

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative, 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 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 analomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

The system transmits ultrasound energy from either a transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PV) 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 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, legs and abdomen; 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 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.

{9}------------------------------------------------

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.

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

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)

Mechal D. OHara

Division Sign-Off -Office of In Vitro Diagnostic Devices Division of Radiological Health (DRH)

K132654 510(k)_

Page 1 of 14

{10}------------------------------------------------

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	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^a	P		P
Abdominal	P	P	P	P	P	P		P^a	P
IntraoperativeAbdominal	P	P	P	P	P	P		P^a	P
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P		P^a	P	P	P
Small Organ(specify)
NeonatalCephalic
Adult Cephalic	P	P	P	P	P	P		P^a	P
Cardiac	P	P	P	P	P	P		P^a	P	P	P
Trans-esophageal	P	P	P	P	P			P^a		P
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P		P^a			P
Peripheral Vessel	P	P	P	P	P	P	P	P^a	P
Laparoscopic
Musculo-skeletalConventional	P	P	P		P	P	P	P^a	P
Musculo-skeletalSuperficial	P	P	P		P	P	P	P^a	P
Other (NeonatalCardiac)	P	P	P	P	P	P		P^a	P
Other (Intra-Cardiac)	P	P	P	P	P	P		P^a			P

N=new indication. P = Previously Cleared in 510(k) K072365, K 102017, K 113179

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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k) -

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

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) K072365, K102017, K113179

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) . Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)__

Page 3 of _ 14

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

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) K072365, K102017

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices 510(k)_

Page 4 of _ 14

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

VSM

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	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) K072365, K 102017, K 113179

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)_ 100 million and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the

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

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) K072365, K102017, K113179

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

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)___

Page 6 of 14

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

510(k) Number (if known):

8V3

Device Name: 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)
NeonatalCephalicAdult 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 (NeonatalCardiac)	P	P	P	P	P	P	P *	P

N=new indication. Previously Cleared in 510(k) K102017, K113179

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

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)_

Page 7 of 14_

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

510(k) Number (if known):

CW2

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	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-skeletalSuperficiat
Other (specify)

N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

	Division Sign-Off -Office of In Vitro Diagnostic Devices
--	----------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k)_

Page 8 of 14

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

510(k) Number (if known):

4Zlc

Device Name: Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Combined{Specify}	Other:HurmonicImaging	Other:RenlTime3D
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	Pa	P	P
Trans-csophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N=new indication. P = Previously Cleared in 510(k) K072365. K 102017, K 113179

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 9 of _ 14

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

AcuNay 8F and 10F Ultrasound Catheter

510(k) Number (if known):

Device Name:

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) K071234, K093812, K 113179

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

Page 10 of 14

510(k)_

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

510(k) Number (if known):

Device Name:

ACUSON AcuNav™ V 10F Ultrasound Catheter

Intended Use:

ClinicalApplication	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
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) K081808, K 113179

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

14 Page 11 of _

510(k)

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

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) K070242, K113179

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k) _______________________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

V7M

Intended Use:

Device Name:

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) K111674

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)

Page 13 of 14

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

510(k) Number (if known):

10V4

Device Name: Intended Use:

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

ClinicalApplication	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	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
IntraoperativeNeurological	P	P	P	P	P	P		P *	P
Pediatric	P	P	P	P	P	P		P *	P
Small Organ(specify)
NeonatalCephalicAdult 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 (Neonatal)	P	P	P	P	P	P	P		P *	P

N=new indication. Previously Cleared in 510(k) K111674

Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off -Office of In Vitro Diagnostic Devices

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 14 of _ 14

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.