# K041499: Ssa-770A, Aplio Version 5.5

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 10, 2004 after 3 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894632 (1989). 38 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2003) Summary page 1.

## Most influential descendants
- K053043: Encompass Software Package (2005), 0 descendants of its own
- K050380: Xario Diagnostic Ultrasound System, Model Ssa-660A (2005), 0 descendants of its own

## Recalls of this device
- Nov 12, 2007 · Not classified · Z-1171-2010: Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA
- Nov 12, 2007 · Not classified · Z-1172-2010: Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA
- Feb 2, 2007 · Not classified · Z-0985-2007: When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement dis

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

Source page: https://510kreport.com/device/K041499
Methodology: https://510kreport.com/methodology