Diagnostic imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Description

The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

AI/ML Overview

The provided text is a 510(k) summary for the ACUSON CV70 Cardiovascular System, a diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and safety standards. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical evaluation.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or detailed device performance metrics from a study.
Sample size used for the test set and the data provenance: There is no mention of a test set or clinical study data. The document focuses on regulatory compliance and device description.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set or ground truth establishment is described, this information is not present.
Adjudication method for the test set: No test set means no adjudication method is discussed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: There is no indication of any MRMC study or AI assistance capability for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as a diagnostic ultrasound system with various imaging modes, implying human operation, not a standalone algorithm.
The type of ground truth used: No ground truth is mentioned.
The sample size for the training set: There is no mention of a training set as no machine learning/AI component is described.
How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

Summary of what the document does provide regarding the device validation:

The document primarily establishes the device's substantial equivalence to previously cleared predicate devices (SONOLINE G50 & G60 S, and ACUSON Sequoia) by comparing its technological characteristics and intended uses. It also lists the product safety standards the device has been designed to meet (UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, ISO 10993).

The FDA's clearance letter requests a "postclearance special report" containing "complete information, including acoustic output measurements based on production line devices." This indicates that performance data (specifically acoustic output) would be collected post-clearance to confirm safety, but it's not a pre-market study establishing efficacy or meeting performance criteria in the way your questions imply.

Summary

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Ultrasound Group

ACUSON CV70 Cardiovascular 510(k) Submission

510(K) SUMMARY

CV70 Cardiovascular system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

Submitted By: 1.

Siemens Medical Solutions USA, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98029

Contact Person:

Carev Chavez Regulatory Affairs

Phone: (425) 557-1683 FAX: (425) 391-9198

Date Prepared:

May 19, 2003

2. Proprietary Name:

ACUSON CV70 Cardiovascular System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550
Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYC
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

3. Predicate Device:

K020353, 2/13/2002, cleared as the Omnia X/XS, marketed as the SONOLINE G50 and SONOLINE G60 S. K022567, 8/13/2002, cleared as Sequoia Signature II

4. Device Description:

The CV70 has been designed to meet the following product safety standards:

1 UL 2601-1. Safety Requirements for Medical Equipment
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
이 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound

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

93/42/EEC Medical Devices Directive I
I Safety and EMC Requirements for Medical Equipment
- B EN/IEC 60601-1
- 내 EN/IEC 60601-1-1
- EN/IEC 60601-1-2
트 IEC 1157 Declaration of Acoustic Power
ISO 10993 Biocompatibility I

Intended Uses: 5.

The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

6. Technological Comparison to Predicate Device:

The CV70 is substantially equivalent to the SONOLINE G50 & G60 S, cleared via K020353; and some features of the ACUSON Sequoia, cleared via K022567. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "HEALTH & HUMAN SERVICES USA" written around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

Siemens Medical Solutions USA, Inc. % Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K032111

Trade Name: ACUSON CV 70 Cardiovascular System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 8, 2003 Received: July 9, 2003

Dear Ms. Danielson:

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 ACUSON CV 70 Cardiovascular System, as described in your premarket notification:

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

Transducer Model Number

C5-2 Convex Array C6-2 Convex Array C8-5 Convex Array 5.0C50+ Convez Array 5.0L45 Linear Array 7.5L70 Linear Array LB5-2 Linear Array L10-5 Linear Array VF13-5 Linear Array VF13-5SP Linear Array 7.5L50I Linear Array 7.5L50Q Linear Array LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Sector Array V5Ms Phased Sector Array CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Lygum

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

510(k) Number (if known):

Device Name:

ACUSON CV70 Cardiovascular System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 3
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 3
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Laparoscopic		P	P	P		P	P		BMDC	Note 3
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Prescription Use (Per 21 CFR 801.109)
Daniel R. Kummer

80 510k

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

510(k) Number (if known):

Device Name:

C5-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaqing

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

David B. Leggmn

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

C6-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3
B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Daniel A. Bergman

(Divisio Division productive. Al and Radiological Devi 510(k) Numb

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

510(k) Number (if known):

Device Name:

C8-5 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5
Adult Cephalic
Cardiac		E	E	E		E	E		BMDC	Note 2,3,4,5
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial		E	E	E		E	E		BMDC	Note 2,3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

David R. Seymann

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number

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

510(k) Number (if known).

Device Name:

Intended Use:

5.0C50+ Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional		E	E	E	E	E	E		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial		E	E	E	E	E	E		BMDC	Note 2,3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

David A. Leyman

(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

5.0L45 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

David A. Hegmann

(Division Sign-Off) Division of Reproductive. Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

Device Name:

7.5L70 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

David A. Legum

nivision Sign-Off sion of Reproductive, Abdom . - a Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name:

Intended Use:

LB5-2 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 4,5
Abdominal		P	P	P		P	P		BMDC	Note 4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

David A. Bergman

800 510k

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

510(k) Number (if known):

Device Name:

L10-5 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

David A. Bergman

(Division Division Reproductive. A and Rac 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 3,4,5
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

David R. Legum

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5SP Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color VelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(note 6)		P	P	P		P	P		BMDC	Note 3
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 3
Pediatric		P	P	P		P	P		BMDC	Note 3
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 3
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 3 3D imaging

Note 6 For example: abdominal, vascular

David A. Seymann

(Division Sign-Off Division of Reproductive and Radiological Dev 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

7.5L501 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Clinical Application Amplitude Combined Other Color PWD CWD Velocity A B M Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal BMDC Note 3,4,5 P P P P P Abdominal Intraoperative Note 3,4,5 P P P P P BMDC (Note 6) Intraoperative Neurological Pediatric Small Organ P BMDC Note 3,4,5 P P P P (Note 1) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular P P BMDC Note 3,4,5 P P P Peripheral vessel Laparoscopic Musculo-skeletal P P BMDC Note 3,4,5 P P P Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

David A. Seppman

(Division Sian-Off Division of and Radiological Devices 510(k) Number

一点在线路站 201

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

510(k) Number (if known):

Device Name:

7.5L50Q Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

Clinical Application	Mode of Operation								Combined(Specify)	Other(Specify)
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 3,4,5
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 3,4,5
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 3 3D imaging
B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

LAP8-4 Laparoscopic Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

Mode of Operation Color Clinical Application Color Amplitude Combined Other B M PWD CWD A Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal Intraoperative P P P P P BMDC Note 3,4,5 (Note 6) Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic P P P P P BMDC Note 3,4,5 Musculo-skeletal . Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

David A. Segerson

(Divisio Divis and Ra 510(k) Numb

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

510(k) Number (if known):

Device Name:

P4-2 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Contrast agent imaging Note 7

Daniel Co. Segram

(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number _

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

510(k) Number (if known)

Device Name:

Intended Use:

5.0P10 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation								Other(Specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P		BMDC	Note 2
Abdominal	P	P	P	P	P	P		BMDC	Note 2
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P		BMDC	Note 2
Small Organ
Neonatal Cephalic	P	P	P	P	P	P		BMDC	Note 2
Adult Cephalic
Cardiac	P	P	P	P	P	P		BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Note 2 Ensemble tissue harmonic imaging

Note 7 Contrast agent imaging

David A. Leyman

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices ி(k) Number

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

510(k) Number (if known).

Device Name:

V5Ms Phased Sector Array TEE Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P	P		BMDC	Note 2,3
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

David A. Lynn

(Division Si Division o and Radiologi 510(k) Numbe

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

510(k) Number (if known):

Device Name:

Intended Use:

CW2 Continuous Wave Doppler Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Clinical Application Color Amplitude Combined Other PWD CWD Velocity B M A (Specify) (Specify) Doppler Doppler Imaging Ophthalmic Fetal Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac P Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Leyva

(Division Sign-Off Division of Reproductive, A and Radiological Devices 510(k) Number

May 19, 2003

{23}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

CW5 Continuous Wave Doppler Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Clinical Application Other Amolitude Combined Color PWD CWD Velocity B M A (Specify) Doppler (Specify) Doppler lmaging Ophthalmic Fetal Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular P Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leyman

(Divis oductive, Abdo and Ra 510(k) Num

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.