MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM

• K Number: K042770
• Device Name: MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2004-10-20 ( 15 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

K032111, K041319

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
The device is described as a diagnostic ultrasound system used for imaging and analysis, not for treating conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic imaging or fluid flow analysis of the human body" and "analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the "Device Description" identifies the CV70 as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which is a hardware device that acquires ultrasound echo data. While it is software-controlled and performs image processing, it is not solely 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 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 from the human body.

Therefore, the CV70 falls under the category of a diagnostic 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:

Product codes

90 IYN, 90 IYO, 90 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, Ophthalmic, Fetal, Transrectal, Transvaginal, Transurethral, Intravascular

Indicated Patient Age Range

Neonatal, Adult

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)

K032111, K041319

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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K042770

510(K) SUMMARY

OCT 2 0 2004

ACUSON 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 Division 22010 S.E. 51st Street Issaquah, WA 98029

Contact Person:

Patrick Lynch Regulatory Affairs

Phone: [phone] FAX: [phone]

Date Prepared:

September 3, 2004

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-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

3. Predicate Device:

K032111, 7/18/2003, cleared as ACUSON CV70 Cardiovascular System, K041319, 6/7/2004, cleared as ACUSON Sequoia™ Diagnostic Ultrasound System.

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:

• UL 2601-1, Safety Requirements for Medical Equipment
• 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• 용 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 동 93/42/EEC Medical Devices Directive

1

• 트 Safety and EMC Requirements for Medical Equipment
  • 트 EN/IEC 60601-1
  • . EN/IEC 60601-1-1
  • 포 EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power
• 트 ISO 10993 Biocompatibility

5. Intended Uses:

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 ACUSON CV70, cleared via K032111; and some features of the ACUSON Sequoia, cleared via K041319. 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

2

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

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

Re: K042770

Trade Name: Acuson CV70 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: September 30, 2004 Received: October 5, 2004

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson CV70 Cardiovascular System, as described in your premarket notification:

Transducer Model Number

C5-2 Convex Array C6-2 Convex Array C8-5 Convex Array

5.0C50+ Convex Array 5.0L45 Linear Array 7.5L70 Linear Array

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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 TEE CW2 Continuus Wave Doppler CW5 Continuous Wave Doppler P9-4 Phased Sector Array

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

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

4

Page 2 - Mr. Job

promotion and advertising of your device, please contact the Office of Compliance at (301) 594promotion and advertising of your ac-roos, please and the by reference to premarket 4039. Also, please note the regulation one and information on your responsibilities under the notification (21 CFA for 80777). Only 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,

Nancy C brogdon

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):

ACUSON CV70 Cardiovascular System

Device Name:

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation Color Clinical Application Color Amplitude Combined Other Velocity PWD CWD в M A (Specify) (Specify) Doppler Doppler Imaging Ophthalmic Note 2,3,4,5 P BMDC P P P P P Fetal BMDC Note 2,3,4,5 P P P P P P Abdominal Note 3 Intraoperative P BMDC P P P P (Note 6) Intraoperative P P BMOC Note 3 P P P Neurological Note 2,3,4,5 P P BMDC P P P P Pediatric Small Organ P P BMDC Note 2,3,4,5 P P P P (Note 1) P p BMDC Note 2,3,4,5 p P P P Neonatal Cephalic P P P BMDC Note 2,3 P P P Adult Cephalic Note 2,3,4,5,7 P P BMDC P P P P Cardiac Note 2,3 BMDC p P P P P P Transesophagea! Transrectal Transvaginal Transurethral Intravascular BMDC Note 2,3,4,5 P P P P P P Peripheral vessel BMDC Note 3 P P P P P Laparoscopic Musculo-skeletal Note 2,3,4,5 P BMDC P P P P P Conventional Musculo-skeletal Note 2,3,4,5 P P P BMDC P P P 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

3D imaging Note 3

B&W SieScape panoramic imaging Note 4

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 C

Nancy Creador

(Division Sign-Off)
yngdo
Division of Reproductive, Abdominal,
and Radiological Devices K042770
510(k) Number

6

510(k) Number (if known):

Device Name:

Intended Use:

C5-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:

| 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 | | | | | | | | | | |
| Transurethrai | | | | | | | | | | |
| 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 (K032111); E = added under Appendix E

Note 2 Ensemble tissue harmonic imaging

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)

Dana C. Bergsten

(Division Sigi Division of Renrodi ive, Abdominal, and Radiological Devices 510(k) Number

7

510(k) Number (if known):

Device Name:

Intended Use:

C6-2 Convex Array 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 Combined Other Amplitude Color Velocity CWD A B M PWD (Specify) Doppler Doppler (Specify) Imaging Ophthalmic P P P BMDC Note 2,3,4,5 P P Fetal P BMDC Note 2,3,4,5 P P P P Abdominal Intraoperative Abdominal Intraoperative Neurological P Note 2,3,4,5 p P BMDC Pediatric P P Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular P P P P ြ BMDC Note 2,3,4,5 Peripheral vessel Laparoscopic Musculo-skeletai Conventional Musculo-skeletai Superficial Other (specify)

N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

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)

Thury C. Burdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042770

8

510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System 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 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
(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		E	E	E		E	E		BMDC	Note 2,3,4,5
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) (Society)
N = new indication; P = previously cleared by FDA (K032111); 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

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)
THE WRITE BELOW THIS LINE OF CONTINE Eveluation (ODE) I WRITE BELOW THIS EINE SONNINGE Evaluation (ODE)

Prescription Use (Per 21)CFR 801.109 ance (Division Sign-Off) Division of Reproductive, Abdomin 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 ACOSON OVT o Gardlovacious. System 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 (K032111); 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

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)

Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

Radiological Devices
K Number K042770

10

510(k) Number (if known):

Device Name:

Intended Use:

5.0L45 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System ACUSON CV70 Cardiovascular Oystern
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-skeletaf
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA (K032111); 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

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)

Darrey C. Brandon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042770

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	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		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 (K032111); 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)

Nancy C. Broadon

(Division Sign=Off) Division of Reproduct ve. Abdon and 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 ACUSON OVT o Garanovaooan. 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 (K032111); E = added under Appendix E

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)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042770
510(k) Number

13

510(k) Number (if known):

Device Name:

L10-5 Linear Array Transducer for use with:

Intended Use:

ACUSON CV70 Cardiovascular System 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 (K032111); 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

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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive and Radiological Device 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 ACUSON CV70 Gardiovusounar Oyetshof 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 (K032111); 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)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

15

510(k) Number (if known):

Device Name:

VF13-5SP 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
(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 (K032111); E = added under Appendix E

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

Note 3 3D imaging

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)

Nancy C. Thornton
(Division Sign-Off)

Division of Reproductive, Ab and Radiological Devices 510(k) Number _

16

510(k) Number (if known):

Device Name:

7.5L501 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		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 (K032111); E = added under Appendix E

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

• 3D imaging Note 3
  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)

Vance Eric Brandon

(Division Sign Division of Reproductive, Abdor and Radiological Devices 510(k) Number _

17

510(k) Number (if known):

Device Name:

7.5L50Q Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System AGUSON OVTO Ourorovation of the human body as follows:

Intended Use:

	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 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 (K032111); E = added under Appendix E

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

3D imaging Note 3

B&W SieScape panoramic imaging Note 4

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)

Nancy C. Brogdon

Division S Division of Reproductive, Abdominal Badiological Devices 's ' )(k) Number

18

510(k) Number (if known):

Device Name:

LAP8-4 Laparoscopic Transducer for use with:

Intended Use:

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 3,4,5
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 (K032111); E = added under Appendix E

3D imaging Note 3

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

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)

Nancy C. Houghton

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042770

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 (K032111); E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

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)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

(Division Sigr Division of Reproductive, Abdor and Radiological Devices 510(k) Number -

20

510(k) Number (if known):

Device Name:

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

Intended Use:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic				P	P	P	P		BMDC	Note 2
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		P	P	P	P	P	P		BMDC	Note 2
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

---

Ensemble tissue harmonic imaging Note 2

Contrast agent imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONSULED CONSUL CORPA CCELL Office (During Freeketing (ODE) TWRITE BEEOW THIS ERE 607Device Evaluation (ODE)

Nancy C. Brigdon

(Division S Division of Reproductive, Abdominal, ano Radiological Devices 5 : ' )(k) Number

21

510(k) Number (if known):

Device Name:

V5Ms Phased Sector Array TEE Transducer for use with:

Intended Use:

ACUSON CV70 Cardiovascular System 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 (K032111); 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)

Nancy C. Bogdon

(Division Sign Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

22

510(k) Number (if known):

Device Name:

CW2 Continuous Wave Doppler Transducer for use with: ACUSON CV70 Cardiovascular System

Intended Use:

AU000N on on on 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
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 (K032111); 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)

Nancy C. Bardin

nt Ronroductive, Ab and Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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
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
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA (K032111); 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)

Harrey C. Brogden
(Division Sign-Off)

Division of Rom and Radiolor 510(k) Nomar

bdominal,
K04277

24

510(k) Number (if known):

Device Name:

Intended Use:

P9-4 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System ACUSON CVTV Gardiovasounar Oyetshof 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
Abdominal		P	P	P	P	P	P		BMDC	Note 2
Intraoperative
Abdominal
Intraoperative
Neurological		P	P	P		P	P		BMDC	Note 2
Pediatric		P	P	P	P	P	P		BMDC	Note 2
Small Organ		P	P	P	P	P	P
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2
Adult Cephalic		P	P	P	P	P	P
Cardiac		P	P	P	P	P	P		BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA (K042044); E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

Contrast agent imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE IF NEEDED)
CONSULERS (CONSUL CORPO, Office (Contine (ORE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. hogdon

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