# K032111: Acuson CV70 Cardiovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 18, 2003 after 9 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935595 (1995). 15 ancestors in all.
955 later devices descend from it; 4 cite it directly.
2 of 971 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 1.
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 1.

## Most influential descendants
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems (2004), 950 descendants of its own
- K042770: Modification to Acuson CV70 Cardiovascular System (2004), 932 descendants of its own
- K050240: Modification to Acuson CV70 Cardiovascular System (2005), 927 descendants of its own
- K043016: Sonoline Orchid Diagnostic Ultrasound System (2004), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own

## Recalls of this device
- Jun 4, 2008 · Not classified · Z-2212-2008: System may either display incorrect mechanical and thermal index values, or fail to display them altogether.

## Indications for use
The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesoptwgeal. Pelvic, NeonataIIAdult 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.

Source page: https://510kreport.com/device/K032111
Methodology: https://510kreport.com/methodology