# K033196: Sonoline Antares with Clarify VE

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 16, 2003 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
No predicates in its family tree.
990 later devices descend from it; 5 cite it directly.
2 of 991 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 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

## Recalls of this device
- Mar 1, 2010 · Not classified · Z-1853-2011: Image captured from the device may be erroneous.

Source page: https://510kreport.com/device/K033196
Methodology: https://510kreport.com/methodology