Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001

• • Terminated Z-1997-2010 FDA Unclassified (pre-2012) ·initiated 5 Jan 2010 ·on shared 510(k) K092179

  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 setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG (

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K092179 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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