# K962142: Sonoline Versa 555 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 29, 1997 after 360 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945773 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945773: Siemens Sonoline Versa, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K945072: Siemens Q4000, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging and Doppler analysis of the human body as follows:

Source page: https://510kreport.com/device/K962142
Methodology: https://510kreport.com/methodology