# K970034: SD 800 Sonodiagnost Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Mar 17, 1997 after 73 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K935923 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935923: Philips Ultrasound P800 Imaging System, Hewlett-Packard Co. (1994) Summary page 1.

Source page: https://510kreport.com/device/K970034
Methodology: https://510kreport.com/methodology