# K971116: Sonos 5500 Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Jan 12, 1998 after 292 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 K944048 (1995). 1 ancestor in all.
190 later devices descend from it; 1 cites it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944048: Ultrasound 77030 Imaging System, Hewlett-Packard Co. (1995) Summary page 1.

## Most influential descendants
- K990339: Sonos 5500 Imaging System M2424A Version B.O (1999), 189 descendants of its own
- K072164: DC-6 Diagnostic Ultrasound System (2007), 188 descendants of its own
- K080640: M5 Diagnostic Ultrasound System (2008), 182 descendants of its own
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own
- K083001: M5 Diagnostic Ultrasound System (2008), 179 descendants of its own

## Indications for use
Diagnostic Ultrasound Imaging of the human body in the applications detailed below.

Source page: https://510kreport.com/device/K971116
Methodology: https://510kreport.com/methodology