# K091295: Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: May 15, 2009 after 11 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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: 11 generations back to K894632 (1989). 56 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082119: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0, Toshiba America Medical Systems, In.C (2008) Summary page 4.

## Most influential descendants
- K093171: Viamo  Ssa-640A Version 1.2 (2009), 11 descendants of its own
- K092179: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001 (2009), 9 descendants of its own
- K103629: Pet-512MC Transesophageal Transducer (2011), 6 descendants of its own
- K161960: bk2300 (2016), 5 descendants of its own
- K142197: Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2 (2014), 5 descendants of its own

## Recalls of this device
- Aug 5, 2013 · Class II · Z-0122-2014: The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mo
- Jun 2, 2010 · Not classified · Z-2981-2011: Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the

## Indications for use
The Aplio v4.0 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 and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K091295
Methodology: https://510kreport.com/methodology