# K954028: HP Sonos Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Aug 8, 1996 after 346 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935009 (1994). 2 ancestors in all.
192 later devices descend from it; 2 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935009: Pegasus, Advanced Technology Laboratories, Inc. (1994) Summary page 1.
- K933743: SSA-380A, Toshiba America Medical Systems, In.C (1994) Summary page 1.

## Most influential descendants
- K972348: HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System (1997), 190 descendants of its own
- 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

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2387-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2388-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

## Indications for use
This modification has no effect on intended use of the HP ultrasound systems.

Source page: https://510kreport.com/device/K954028
Methodology: https://510kreport.com/methodology