# K992046: Sonoline 7XX Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 13, 1999 after 57 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: 3 generations back to K935595 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K981528: Sonoline Elegra Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

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

Source page: https://510kreport.com/device/K992046
Methodology: https://510kreport.com/methodology