Modification to: Eub-8500 Diagnostic Ultrasound Scanner

• • Terminated Z-2055-2009 FDA Unclassified (pre-2012) ·initiated 12 May 2008 ·on shared 510(k) K013722

  The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.

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

510(k) Number

K013722 ↗

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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  Class II

  FDA 510(k) K011252 Active Cleared 30 May 2001

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