# K020353: Omnia X/XS Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Feb 13, 2002 after 9 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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.
1,026 later devices descend from it; 9 cite it directly.
2 of 1,029 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.

## Most influential descendants
- K032111: Acuson CV70 Cardiovascular System (2003), 955 descendants of its own
- 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
- K040502: Sonoline Ebisu Diagnostic Ultrasound Systems (2004), 930 descendants of its own
- K042833: Sonoline G20 Diagnostic Ultrasound Systems (2004), 928 descendants of its own

## Indications for use
Diagnostic imaging or fluid flow analysis of the human body as follows: Ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K020353
Methodology: https://510kreport.com/methodology