MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM

K050240 · Siemens Medical Solutions USA, Inc. · IYN · Feb 15, 2005 · Radiology

Device Facts

• Record ID: K050240
• Device Name: MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, intraoperative, Small Parts, Peripheral Vascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis to provide information that is used for clinical diagnosis purposes.

Device Story

The ACUSON CV70 is a mobile, software-controlled diagnostic ultrasound system. It transmits ultrasonic energy into the body via various transducers (convex, linear, phased array, and intravascular catheter) and processes received echoes to generate images. Modes include B-Mode, M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Harmonic Imaging, and 3D imaging. The system displays thermal and mechanical indices for bioeffect monitoring. It is used in clinical settings by healthcare professionals for anatomical measurements and flow analysis to aid in diagnosis. Output is presented on a CRT display, assisting clinicians in visualizing structures and blood flow to inform clinical decision-making.

Clinical Evidence

Bench testing only. The device complies with recognized safety and performance standards, including UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2, and AIUM/NEMA UD-3. Biocompatibility is addressed per ISO 10993-1. No clinical trial data was required for this clearance.

Technological Characteristics

Mobile ultrasound system; software-controlled. Transducers: convex, linear, phased array, and intravascular catheter. Imaging modes: B, M, PW/CW Doppler, Harmonic, 3D. Connectivity: CRT display. Safety standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3. Biocompatibility: ISO 10993-1. Software: embedded, system-level control.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including abdominal, fetal, pediatric, cardiac, peripheral vascular, musculoskeletal, intraoperative, and intracardiac applications. Patient population includes adults, pediatrics, and neonates. Contraindications are not explicitly stated.

Regulatory Classification

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.

Predicate Devices

• ACUSON CV70 Cardiovascular System (K042770)
• ACUSON Sequoia Diagnostic Ultrasound System (K042593)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 9 2005

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

Re: K050240

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 ultrasound transducer Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: 90 IYN, IYO, ITX and 74 DQO Dated: September 30,2004 Received: February 2,2005

Dear Mr. Job:

This letter corrects our substantially equivalent letter of February 15, 2005 regarding the missing Regulation Number, Name, and Product Code.

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:

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

### Transducer Model Number

| C5-2 Convex Array | 7.5L50I Linear Array |
|-----------------------|-------------------------------|
| C6-2 Convex Array | 7.5L50Q Linear Array |
| C8-5 Convex Array | LAP8-4 Laparoscopic |
| 5.0C50+ Convex Array | P4-2 Phased Sector Array |
| 5.0L45 Linear Array | 5.0P10 Phased Sector Array |
| 7.5L70 Linear Array | V5Ms Phased Sector Array TEE |
| LB5-2 Linear Array | CW2 Continuous Wave Doppler |
| L10-5 Linear Array | CW5 Continuous Wave Doppler |
| VF13-5 Linear Array | P9-4 Phased Sector Array |
| VF13-5SP Linear Array | AcuNav 8F Ultrasound Catheter |

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.

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

{2}------------------------------------------------

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours.

David A. Lyonn

for

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

Enclosure(s)

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

## KOSO240

### 510(K) SUMMARY

### ACUSON CV70™ Cardiovascular system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance This Summaly of Salely and encolvened is provisions 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

## FEB 1 5 2005

### Contact Person:

Patrick Lynch Regulatory Affairs

Phone: [phone] FAX: [phone]

### Date Prepared:

September 3, 2004

#### Proprietary Name: 2.

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 |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code 90-DQC |

#### Predicate Device: 3.

K042770, 10/20/2004, cleared as ACUSON CV70™ Cardiovascular System. K042770, 10/20/2004, cleared as ACUSON Sequoia™ Diagnostic Ultrasound System.

#### Device Description: 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 an on-sereen display for themal and re primary or secondary harmonic ultrasound echo data and modiantinin B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, ulsplay it in. D Mode, it would (f 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 60601-1, Safety Requirements for Medical Equipment 트
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ■
- 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

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

- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound 트
- 93/42/EEC Medical Devices Directive I
- Safety and EMC Requirements for Medical Equipment I
- 트 EN/IEC 60601-1
- EN/IEC 60601-1-1 L
- I EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power I
- ISO 10993-1 Biocompatibility I

#### Intended Uses: 5.

intended USes.
The CV70 ultrasound imaging system is intended for the following applications: Abdominal, I The OVTO ultrasound Integrity of countial, OB/GYN, Cardiac, Intracardiac, Transesophageal, intraoperative, Omall Parts, Pranooranaa, CEravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

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

#### Technological Comparison to Predicate Device: 6.

Technological oompany equivalent to the ACUSON CV70, cleared via K042770; and some The OW For Subolantian) Squoia, cleared via K042593. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of into patients, then portom post prositivin the body. All systems allow for specialized measurements of structures and flow, and calculations.

### End of 510(k) Summary

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

510(k) Number (if known):

### ACUSON CV70 Cardiovascular System

Device Name: Intended Use:

AOOOON of maging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | | |
| 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<br>(Note 6) | | P | P | P | | P | P | BMDC | Note 3 |
| Intraoperative<br>Neurological | | P | P | P | | P | P | BMDC | Note 3 |
| Pediatric | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Small Organ<br>(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 | | N | N | N | N | N | N | BMDC | Note 2,3,7,8 |
| 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<br>Conventional | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Superficial | | N | N | N | N | N | N | BMDC | Note 8 |

(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

SD imaging
B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Intracardiac imaging Note 8

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
> (PLEASE DO NOT WRITE BELOW CERS of Review Evelustion (ODE) | WRITE BEEOW THIS Office of Device Evaluation (ODE)

> > Prescription Use (Per 21 C

510(k) Number

Use (Per 21 CFR 801.109)

Nancyc Brindon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices, V.DE0214

Indications for Use Forms

Page 1 of 20

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

510(k) Number (if known):

Device Name:

Intended Use:

C5-2 Convex 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:

| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

Other (Specily)
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)
> THE CONTINUE OF CONSTIC CORPH Off as of Davise Firelyetion (ODE) | WRITE BEEOW THIS EIRE SORH - Office of Device Evaluation (ODE)

Nancy Broydon

(Division Sign-Of Division of Reproductive and Radiological Devic 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 | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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)

Nancy C bradon

(Division Sig Division of Reproductive, Abdon and Radiological Device 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

C8-5 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal<br>Superficial | | 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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

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. Bridon

(Division Si Division of Reproductive, Abdo and Radiological Device 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 ACUSON CVTV Gardiovaooular Systems of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ<br>(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<br>Conventional | | E | E | E | E | E | E | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal<br>Superficial | | E | E | E | E | E | E | | BMDC | Note 2,3,4,5 |

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

Other (specify)

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 Croydon

(Division Sic Division of Renroduc ive. Al and Radiological Devic 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 ACUSON OVT o Garaitvaoualar Olysis of the human body as follows:

Mode of Operation Color Other Amplitude Combined Clinical Application Color Velocity M PWD CWD B (Specify) A (Specify) Doppler Doppler Imaging Ophthalmic Fetal Note 2,3,4,5 BMDC P P P P P P Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Note 2,3,4,5 BMDC Small Organ P P P P ్రా P (Note 1) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Note 2,3,4,5 BMDC P P P P P P Peripheral vessel Laparoscopic Note 2,3,4,5 Musculo-skeletal BMDC P P P P P P Conventional Musculo-skeletal Superficial Other (specify)

- and (Specification; 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)

Y Daniel C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050240

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

510(k) Number (if known):

Device Name:

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

Intended Use:

AOUOON CVT o Our of our analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Other (specify) | | | | | | | | | | | |

Other (Spoolly)
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

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

Nancy burden

(Division Sign Division of Reproduct and Radiological Device 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 4,5 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 4,5 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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)

Nancy C. Brogdon

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices : 1 %) Number _

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

510(k) Number (if known):

Device Name:

Intended Use:

L10-5 Linear Array 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal<br>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

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 Croydon

(Division Sign-Off)

Division of Reproductive, Abdominal,
Radiological Devices
Number K050240

{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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Small Organ<br>(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<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal<br>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)

Nancy C. Brogdon

(Division Sign-Off Division of Reproductive, Abdi A Radiological Devices 5 = ((k) Number __

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

510(k) Number (if known):

Device Name:

VF13-5SP Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System ACUSON CVT 0 Gardrovasoalar Gyoton.
Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(note 6) | | P | P | P | | P | P | | BMDC | Note 3 | |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note 3 | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3 | |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 3 | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 3 | |
| Other (specify) | | | | | | | | | | | |

(Citier (Open); )
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)
> CONTINUE (CONTINUE OFFICE OFFICE (Projection (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sigh-O Division of Reproductive. Abdor and Radiological Devices 510(k) Number _

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

510(k) Number (if known):

Device Name:

7.5L501 Linear Array Transducer for use with:

Intended Use:

ACUSON CV70 Cardiovascular System ACUSON CVT 0 Cardiovasouna: Gyoten.
Diagnostic imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Intraoperative<br>(Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal<br>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

Note 3 3D imaging

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 L. Brogdon

(Division Division of Reproductive, Abdo 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

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative<br>(Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Musculo-skeletal<br>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

Note 3 3D imaging

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)

Nancyc Brogdon

(Division S Division of Reproductive. Abd and Radiological Devices :- 1 (Kk) Number

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

510(k) Number (if known):

Device Name:

### LAP8-4 Laparoscopic 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

3D imaqinq Note 3

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)

Nancy Chosdon

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 5 (Xk) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

Device Name:

Intended Use:

P4…