# K042770: Modification to Acuson CV70 Cardiovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 20, 2004 after 15 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: 5 generations back to K935595 (1995). 19 ancestors in all.
932 later devices descend from it; 2 cite it directly.
2 of 952 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032111: Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K041319: Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K050240: Modification to Acuson CV70 Cardiovascular System (2005), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer (2005), 806 descendants of its own
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 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, 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.

Source page: https://510kreport.com/device/K042770
Methodology: https://510kreport.com/methodology