Predicate Devices

K072365, K102017, K113179, K123622, K130754

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance metrics indicative of AI/ML.

Therapeutic

No
The device description and intended use state that it is a "diagnostic ultrasound system" and is used for "imaging" and "diagnosis purposes," not for treatment.

Diagnostic

Yes
The "Device Description" explicitly states "The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system...". Additionally, the "Intended Use / Indications for Use" section mentions that the system "provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and describes its function in acquiring and displaying ultrasound echo data. This indicates the presence of hardware components (transducers, display, etc.) in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The SC2000 ultrasound imaging system is described as a diagnostic ultrasound system that uses sound waves to create images of internal anatomical structures. It acquires and displays ultrasound echo data.
Intended Use: The intended use clearly states applications like Cardiac, Abdominal, Musculo-skeletal, etc., which involve imaging the body directly, not analyzing samples taken from the body.
Lack of Mention of Samples: There is no mention of the device processing or analyzing biological samples.

The device is a medical imaging system used for non-invasive diagnosis based on ultrasound technology.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, OBJ

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.

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Peripheral Vessel, Abdominal, Musculo-skeletal (Conventional and Superficial), Adult Cephalic.
Intraoperative: Abdominal
Transesophageal.
Transcranial.

Indicated Patient Age Range

Adult, Pediatric, Neo-natal, Fetal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072365, K102017, K113179, K123622, K130754

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K072786, K111674

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 Division
685 East Middlefield Road
Mountain 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™ 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.

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

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

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 | Acuson
SC2000™
K123622 | Acuson
S2000
K111674 | Acuson
S2000
K072786 | Acuson
SC2000™
This
submission |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------|----------------------------|-----------------------------------------|
| 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 grouping
capabilities and linking to MultiHertz™ multiple frequency
Imaging | 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 color

Doppler 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	x
X	×
X	×
X	X
DIE
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		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 imaging
and High Resolution Color Flow (HRCF)	X	X	x	X
Cadence™ CPS Capture	x	X	X	×
Advanced SieClear™ spatial compounding with Dynamic TCE
TM (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
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1 - 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

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.

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

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

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P^a | P | | P |
| Abdominal | | P | P | P | P | P | P | | P^a | P | | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P^a | P | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P^a | P | P | P |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | P | P^a | P | | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P^a | P | | |
| Other (Neonatal
Cardiac) | | 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

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | P | P | P | P | | P | P | P | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal
Superficial | 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:

*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)__

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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | |
| Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative
Abdominal | | 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 | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other
(Abdominal
Vascular) | | P | P | P | P | P | P | | P* | P | |

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

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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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | | P* | | P | |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

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

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | | 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

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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;

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P * | P | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P * | P | |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P * | P | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Neonatal
Cardiac) | | 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

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficiat | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

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	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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
{Specify} | Other:
Hurmonic
Imaging | Other:
Renl
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | | | P* | P | P |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | p | | | P* | P | P |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | Pa | P | P |
| Trans-csophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| 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

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Page 10 of 14

510(k)_

19

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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | | P | |
| Small Organ
(specify) ** | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| 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:

*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)

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| 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)

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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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|---|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P* | P | P | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | | P* | | P |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

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

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)

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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P * | P | |
| Abdominal | | P | P | P | P | P | P | | P * | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P * | P | |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P * | P | |
| Pediatric | | P | P | P | P | P | P | | P * | P | |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | P | | P * | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Neonatal) | | 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+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 14 of _ 14