ACUSON CV70 CARDIOVASCULAR SYSTEM

• K Number: K032111
• Device Name: ACUSON CV70 CARDIOVASCULAR SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2003-07-18 ( 9 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K020353, K022567

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities in the device description, intended use, or other sections.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" used for "diagnostic imaging or fluid flow analysis" and for obtaining "information that is used for clinical diagnosis purposes," indicating its role in diagnosis rather than therapy.

Diagnostic

Yes
The Intended Use section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the Device Description refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components for acquiring ultrasound data (transducer, beamformer, etc.) in addition to the software control and display.

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 Description: The description clearly states that the CV70 is a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
• Intended Use: The intended use describes diagnostic imaging and fluid flow analysis of the human body, not analysis of samples taken from the body.

Therefore, the CV70 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

Clinical Application	Mode of Operation A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	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
Intraoperative Neurological		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-skeletal Conventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Musculo-skeletal Superficial		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
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging

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

90-IYN, 90-IYC, 90-ITX, 90 IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Fetal, Breast, Testes, Thyroid, Penis, Prostate

Indicated Patient Age Range

Neonatal/Adult, Pediatric, 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)

Not Found

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.

K020353, K022567

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.

Not Found

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

§ 892.1550 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.

Summary

0

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: [phone] FAX: [phone]

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 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.

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

J

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:

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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.

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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:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Neurological		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-skeletal
Conventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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

(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 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

David B. Leggmn

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

7

4

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		E	E	E	E	E	E		BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
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

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P	P	P	P		BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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

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

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	Color
Doppler	Amplitude
Doppler	Color Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(note 6)		P	P	P		P	P		BMDC	Note 3
Intraoperative
Neurological		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-skeletal
Conventional		P	P	P		P	P		BMDC	Note 3
Musculo-skeletal
Superficial		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

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

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

(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)

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 | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | | |
| 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 |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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

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

(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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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 | A | Mode of Operation | | | | | | | | Other
(Specify) |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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

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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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