# K051500: Famio Diagnostic Ultrasound Systems, Model Ssa-530A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 17, 2005 after 10 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: 6 generations back to K935595 (1995). 21 ancestors in all.
195 later devices descend from it; 2 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010631: NEMIO, Toshiba America Medical Systems, In.C (2001) Summary page 1.
- K043078: Nemio Diagnostic Ultrasound System, Model Ssa-550A, Toshiba America Medical Systems, In.C (2004) Summary page 1.

## Most influential descendants
- K053346: Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900 (2005), 194 descendants of its own
- K061189: DP-9900 Digital Ultrasonic Diagnostic Imaging System (2006), 193 descendants of its own
- K063500: DC-6 Diagnostic Ultrasound System (2006), 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

## Indications for use
The FAMIO SSA-530A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular and, musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K051500
Methodology: https://510kreport.com/methodology