# K092179: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jul 29, 2009 after 8 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: 12 generations back to K894632 (1989). 58 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091295: Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K090334: Acuson S2000 Diagnostic Ultrasound System, Siemens Medi Cal Solutions, Inc. (2009) Summary page 1.

## Most influential descendants
- K103629: Pet-512MC Transesophageal Transducer (2011), 6 descendants of its own
- K161960: bk2300 (2016), 5 descendants of its own
- K180737: Ultrasound Scanner System bk2300 (2018), 2 descendants of its own
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own
- K173569: Ultrasound System 1300 (2018), 1 descendant of its own

## Recalls of this device
- Jan 5, 2010 · Not classified · Z-1997-2010: Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction set

## Indications for use
Elastography is indicated for determining the relative elasticity of a lesion.

Source page: https://510kreport.com/device/K092179
Methodology: https://510kreport.com/methodology