# K042044: Acuson CV70 Cardiovascular System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 13, 2004 after 14 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: 4 generations back to K935595 (1995). 16 ancestors in all.
429 later devices descend from it; 1 cites it directly.
0 of 446 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.

## Most influential descendants
- K061946: Acuson X300 Diagnostic Ultrasound System (2006), 428 descendants of its own
- K071036: Modification to Acuson X300 Ultrasound System (2007), 427 descendants of its own
- K083149: Arterial Health Package (Ahp) Software (2009), 330 descendants of its own
- K072676: Acuson X300 Ultrasound System (2007), 279 descendants of its own
- K080760: Acuson X300 Ultrasound System (2008), 278 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 platform is intended for use in the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, and intended uses as defined in the FDA guidance document. 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/K042044
Methodology: https://510kreport.com/methodology