← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K032111
# ACUSON CV70 CARDIOVASCULAR SYSTEM (K032111)
_Siemens Medical Solutions USA, Inc. · IYN · Jul 18, 2003 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K032111
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Jul 18, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric, 3rd-Party Reviewed
## Intended 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.
## Device Story
The ACUSON CV70 is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers (convex, linear, phased sector, CW Doppler). The system processes these inputs to display images in B-Mode, M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, Harmonic Imaging, and 3D imaging on a CRT display. Operated by clinicians in clinical settings, the device provides anatomical measurements and analysis packages. The output is used by healthcare providers to assist in clinical diagnosis and decision-making, potentially benefiting patients through non-invasive visualization and assessment of internal structures and blood flow.
## Clinical Evidence
Bench testing only. The device complies with UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3 (1998), AIUM/NEMA UD-2 (1998), IEC 1157, and ISO 10993 biocompatibility standards. No clinical data was required for this 510(k) clearance.
## Technological Characteristics
Mobile, software-controlled diagnostic ultrasound system. Transducers: convex, linear, phased sector, and CW Doppler arrays. Imaging modes: B, M, PW/CW/Color/Amplitude Doppler, Harmonic, and 3D. Connectivity: CRT display, on-screen thermal/mechanical indices. Safety: UL 2601-1, IEC 60601-1, ISO 10993. Software-controlled signal processing.
## Regulatory 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
- Omnia X/XS (SONOLINE G50 and SONOLINE G60 S) ([K020353](/device/K020353.md))
- Sequoia Signature II ([K022567](/device/K022567.md))
## Submission Summary (Full Text)
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Ultrasound Group
ACUSON CV70 Cardiovascular 510(k) Submission
## 510(K) SUMMARY
### CV70 Cardiovascular system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
#### Submitted By: 1.
Siemens Medical Solutions USA, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98029
### Contact Person:
Carev Chavez Regulatory Affairs
Phone: (425) 557-1683 FAX: (425) 391-9198
# Date Prepared:
May 19, 2003
#### 2. Proprietary Name:
ACUSON CV70 Cardiovascular System
### Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
## Classification Name:
| 21 CFR 892.1550 | | |
|------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYC |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
#### 3. Predicate Device:
K020353, 2/13/2002, cleared as the Omnia X/XS, marketed as the SONOLINE G50 and SONOLINE G60 S. K022567, 8/13/2002, cleared as Sequoia Signature II
#### 4. Device Description:
The CV70 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
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- 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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Lygum
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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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
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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 | | | | | | | | | | |
|…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K032111](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K032111)
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