# K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 2, 2006 after 20 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (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.
205 later devices descend from it; 2 cite it directly.
0 of 244 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
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 (2007), 203 descendants of its own
- K072826: Aplio Artida Diagnostic Ultrasound System (2007), 182 descendants of its own
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System (2008), 181 descendants of its own
- K081065: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 (2008), 118 descendants of its own
- K082119: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 (2008), 116 descendants of its own

## Recalls of this device
- Oct 2, 2007 · Not classified · Z-0305-2008: Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to

## Indications for use
The Aplio XG System is intended to be used for the following types of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculoskeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K063130
Methodology: https://510kreport.com/methodology