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 Neurological, 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Siemens Acuson SC2000™ Diagnostic Ultrasound System. It's important to note that this document is a 510(k) summary for a modification to an already cleared device, and the focus is on demonstrating substantial equivalence, rather than proving performance from scratch for a novel device.

Acceptance Criteria and Study for Siemens Acuson SC2000™ Diagnostic Ultrasound System (Modification K123622)

This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified Acuson SC2000™ Diagnostic Ultrasound System to previously cleared predicate devices. Therefore, the "acceptance criteria" and "study" are framed in terms of compliance with regulatory standards and comparison to existing, cleared technology, rather than novel clinical performance endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety - Hardware	Compliance with UL 60601-1 (Safety Requirements for Medical Equipment).	The device is "designed, verified, and validated according to the company's design control process" and "meets all of its specifications." Explicitly states "Hardware Safety - EN60601-1 Certified."
Safety - Software	Compliance with EN60601-4 (Software Safety).	"Software Safety - EN60601-4 Certified."
Safety - Acoustic Thermal	Compliance with IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards). Compliance with AIUM/NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment). Compliance with AIUM/NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound).	"Acoustic Thermal Safety - EN60601-2-37 Certified." "Compliance is verified through independent evaluation with ongoing factory surveillance."
Safety - EMC	Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2 (EMC Requirements for Medical Equipment).	"Compliance is verified through independent evaluation with ongoing factory surveillance." Explicitly states compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2.
Safety - Biocompatibility	Compliance with ISO 10993-1 (Biocompatibility). For transducers, "Same transducers no new materials" implies continued biocompatibility.	"Biocompatibility - Same transducers no new materials" for all listed transducers. "Biocompatibility" for the Respirometer accessory.
Quality System	Compliance with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards.	"The design and development process of the manufacturer conforms with 21CFR820 Quality System Requlation and ISO 13485:2003 quality system standards."
Intended Use	The intended uses for the modified device and its transducers are substantially equivalent to previously cleared devices.	Detailed tables for the main system and each transducer (9L4, V5M TEE, 4V1c, 8V3c, AUX CW2, 4Z1c, AcuNav 8F/10F, ACUSON AcuNav™ V 10F, SoundStar 10F, V7M TEE, 10V4) explicitly indicate "P = Previously Cleared in 510(k)" for specific clinical applications and imaging modes. No "N=new indication" is present for the system itself, only for some transducer tables where 'P' indicates presence in prior 510(k)s.
Technological Characteristics	The technological characteristics of the modified device are substantially equivalent to, or improve upon while maintaining safety and effectiveness, those of previously cleared predicate devices.	A comparison table (page 2) lists various hardware, software, transducer, accessories, imaging, and calculation features. All features are marked as present in either the previous SC2000™ (K113179), S2000 (K111674), X300 (K121699), or the current submission, demonstrating consistency or updates within a predicate framework.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the traditional sense for this submission. The 510(k) is for a modification to a previously cleared ultrasound system. The primary "test" is demonstrating compliance with recognized standards and comparison to predicate devices.
Data Provenance: The document does not describe specific clinical test datasets. Instead, it relies on:
- Prior Clearances: K072365, K102017, K113179 (for the SC2000), K111674 (for the S2000), K121699 (for the X300).
- Nonclinical Tests: The submission relies on "extensive safety and performance testing" according to the company's design control process, and verification that the device "meets all of its specifications" (page 4).
- Standards Compliance: This includes documented adherence to various IEC, UL, CSA, AIUM/NEMA, and ISO standards (e.g., IEC 60601-1, ISO 10993-1).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No new clinical reader studies are described in this 510(k) summary because the device is a modification and relies on substantial equivalence to predicate devices, supported by nonclinical safety and performance testing.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no new clinical test set requiring expert adjudication is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. The submission explicitly states: "Since the SC2000 uses the same technology and principles as existing devices, clinical data is not required." (page 4)
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance feature is mentioned or evaluated in this 510(k) summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This document describes a diagnostic ultrasound system (hardware and software), not a standalone algorithm. The "performance" assessment is based on meeting engineering specifications, safety standards, and equivalence to existing ultrasound technology.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety, effectiveness, and intended use of the predicate devices and the requirements of recognized regulatory standards. The modified device demonstrates its "ground truth" by showing it adheres to these established benchmarks through nonclinical testing (e.g., electrical safety, acoustic output, EMC, biocompatibility) and direct comparison of features to cleared devices.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This refers to a medical device system, not an AI/machine learning algorithm that requires a training set. The development process involved design, verification, and validation, but not in the sense of training a model on a dataset.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of an AI/machine learning component requiring a training set in this 510(k) summary. The development relies on engineering principles, compliance with medical device standards, and substantial equivalence to predicate devices, which collectively establish its "ground truth" for regulatory clearance.

Summary

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510(k) Summary Prepared October 18, 2012

DEC 0 5 2012

1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
Contact Person: Patrick J. Lynch (650) 694-5658 Telephone: (650) 694-5580 Fax:
Acuson SC2000™ Diagnostic Ultrasound System 2. Device Name:
Common Name: Diagnostic Ultrasound System

Classification:

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

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Intravascular Catheter	FR # 870.1200	Product Code OBJ

3. Legally Marketed Predicate Devices

The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K113179, the Acuson S2000 (K111674) and the Acuson X300 (K121699).

4. 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)

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5. Intended 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, Intraoperative Abdominal, Intraoperative Neurological, 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 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, creat 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 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.

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

Superficial Imaging Applications

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

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological 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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6. Summary of Technological Characteristics -- New Device Compared to Predicate

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

Description	AcusonSC2000TMK113179	AcusonS2000K111674	AcusonX300K121699	AcusonSC2000TMThissubmission
System:
Hardware Safety - EN60601-1 Certified	X			X
Software Safety - EN60601-4 Certified	X			X
Acoustic Thermal Safety - EN60601-2-37 Certified	X			X
Transducers:
See Table in Section 4.4.1.4 - All previously cleared	X			X
Biocompatibility - Same transducers no new materials	X			X
V7M Transducer		X	X	X
10V4 Transducer		X	X	X
AcuNav 8F/10F	X			X
AcuNav V	X			X
Soundstar 10F	X			X
Biocompatibility - Same transducers no new materials	X			X
Accessories:
Respirometer	X			X
Biocompatibility	X			X
AcuNav Joystick	X			X
Imaging:
SpaceTimeTM resolution control	X			X
NativeTM Tissue Harmonic Imaging	X			X
MultiHertz multiple frequency imaging	X			X
RESTM enhanced resolution imaging format	X			X
Output display standard compliance	X			X
Native TEQTM dynamic ultrasound technology	X			X
TEQTM ultrasound technology	X			X
TEQTM technology for Spectral PW and CW Doppler	X			X
Dual screen and live dual imaging	X			X
Acoustic clip capture	X			X
eSie Measure Workflow Acceleration	X			X
Preset functionality with preset ordering and groupingcapabilities and linking to MultiHertzTM multiple frequencyimaging	X			X
Integrated Stress echo capability	X			X
Cardiac imaging and quantification package			X
DTI™ Doppler tissue imaging includes the following colorDoppler capabilities:	X		X
DTI Velocity (DTV)	X		X
Color Doppler Harmonic capability in DTI	X		X
High Frame Rate Tissue Doppler (HTD) Capability	X		X
DTI Energy (DTE)	X		X
Color Doppler Velocity (CDV)	X		X
Color Harmonic imaging	X		X
DTI Pulsed Wave (DTI PW) capability	X		X
Color Doppler M-Mode for:	X		X
CDV	X		X
DTV	X		X
DTE	X		X
Contrast Imaging
Cadence™ contrast pulse sequencing technology (CPS)	X		X
PrecisonBurst programmable triggering for contrast agentdestruction	X		X
TEQ and NTEQ ultrasound technology for Cadence™ CPS	X		X
Cardiac Calculations:
Cardiac calculations package	X		X
Slope Line calculations	X		X
Generic Calculations/Ratio function	X		X
Vascular imaging package
B-mode, M-mode, NTHI, CPS, PW Doppler, Triplex imagingand High Resolution Color Flow (HRCF)	X		X
Cadence™ CPS Capture	X		X
Advanced SieClear™ spatial compounding with Dynamic TCETM (tissue contrast enhancement) technology	X		X
Advanced Vascular Analysis report package	X		X
Clarify™ Vascular Enhancement Technology	X		X
Linear and Vector imaging formats	X		X
Auto Doppler option	X		X
Time averaged velocity (TAV) calculation	X		X
Vascular Calculation package	X		X
Transcranial imaging	X		X
Application packages:
syngo® Mitral Valve Assessment	X		X
syngo® auto Ejection Fraction technology	X		X
D1ART with syngo® fourSight™ TEE view	X		X
syngo® Quantitative Synch Tools™ technology (QST)	X		X
syngo® Velocity Vector Imaging™ technology (VVI) rotation	X		X
syngo® ACQ auto-tracking contrast quantification	x			x
Connectivity:
Wireless Network Connectivity			x	x
DICOM Print Service	x			x
DICOM Media Storage Service	x			x
DICOM Structured Reporting	x			x

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

The 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 .
이 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ■ 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
. ISO 10993-1 Biocompatibility

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalent

Since the SC2000 uses the same technology and principles as existing devices, clinical data is not required.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21CFR820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the SC2000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 5, 2012

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

Re: K123622

Trade/Device Name: SC2000TM 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: November 21, 2012 Received: November 23, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Transducer Model Number

9L4	AcuNav 8F and 10F Ultrasound Catheter
V5M TEE	ACUSON AcuNav™ V 10F Ultrasound
4V1c	Catheter
8V3c	SoundStar 10F Ultrasound Catheter
AUX CW2	V7M TEE
4Z1c	10V4
	ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),

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it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

Michael D. O'Hare

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

Enclosure(s)

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510(k) Number (if known):

Device Name:

SC2000™ Diagnostic Ultrasound System

Indications for 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 of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system transmits ultrasound energy from either a transthoracic or 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 (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 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 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.

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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)

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Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)

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Muhal D. O'kin
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Office of In Vitro Diagnostics and Radiological Health

510(k) K123622

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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
IntraoperativeAbdominal	P	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*	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*	P
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P*			P

N=new indication. P = 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

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Prescription Use (Per 21 CFR 801.109)

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Office of in Vitro Diagnostics a

510(k) K123622

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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	P	P	P	P	P	P	P*	P
Pediatric
Small Organ(specify)
NeonatalCephalicAdult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal
Peripheral Vessel	P	P	P	P	P	P	P*	P
Laparoscopic	P	P	P	P	P	P	P*	P
Musculo-skeletalConventional	P	P	P	P	P	P	P*	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P*	P
Other (specify)

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

Additional Comments:

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510(k) K123622

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510(k) Number (if known):

Device Name:

V5M TEE

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) K072365, K102017, K113179

Additional Comments:

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Prescription Use (Per 21 CFR 801.109)

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Page 4 of

Division of Radiological Health

Office of In Vitro Diagnostics and Rac

510(k) K123622

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

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)
NeonatalCephalicAdult 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

510k

Additional Comments:

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Michael D. O'Hare

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Page 5 of

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Division of Radiological Health

Office of In Vitro Di ical Health

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

510(k) Number (if known):

Device Name:

8V3c

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:

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

Minh D. O'Kee
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Division of Radiological Healt

Jitice of In Vitro Diagnostics and Radiological Health

510(k) K123622

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

510(k) Number (if known):

Device Name:

AUX CW2

Intended Use:

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

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

N=new indication. Previously Cleared in 510(k) 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 and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Michael D'John

Page 7 of

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Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123622

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

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
lntraoperativeNeurological
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) 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 and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Mhhel D.O.Thm
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Page 8 of

Division of Radiological Health

Office of In V

5100 K123622

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

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) K071234, K093812, 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

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Page 9 of

Division of Radiological He

Office of In V

510(k) K123622

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

510(k) Number (if known):

Device Name:

ACUSON AcuNav™ V 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)	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) K081808, K113179

Additional Comments:

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

escription Use (Per 21 CFR 801.109)

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Page 10 of

Division of Radiological He

Office of In Vitro Diagnostic

510(k) K123622

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

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 and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

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Page 11 of

Division of Radiological Hess

Office of In Vitro Diagnostics

510(k) K123622

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

510(k) Number (if known):

Device Name:

V7M TEE

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) K111674

Additional Comments:

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

Michael D. Oker

Page 12 of __

(Division Sign Off) Division of Radiological Health

Office of In Vitro Diagnostics and Radiolo

: 510(K) K123622

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

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	ColorVelocityImaging	Combined(Specify)
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	P	P	P	P	P	P	P	P*	P
Pediatric	P	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 (NeonatalCardiac)	P	P	P	P	P	P	P	P*	P

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

Additional Comments:

*Combinations include: B+M, B+PWD, 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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Page 13 of

Division of Radiological Health Office of In Vitro Diagnostics and Radiological

510(k) K123622

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.