Modification to: Eub-6500 Diagnostic Ultrasound Scanner

• • Terminated Z-2054-2009 FDA Unclassified (pre-2012) ·initiated 12 May 2008

  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.

• • Terminated Z-1005-04 FDA Unclassified (pre-2012) ·initiated 7 May 2004

  Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.

510(k) Number

K013723 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Eub-6500 Diagnostic Ultrasound Scanner

  Class II

  FDA 510(k) K053258 Active Cleared 9 Dec 2005

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  Class II

  FDA 510(k) K160559 Active Cleared 18 Oct 2016

• Eub-555

  Class II

  FDA 510(k) K926209 Active Cleared 3 Jun 1994

• Oasis Ctl Coil, Od Flexible Body Coil (L and Xl), and Rapid Foot Coil

  Class II

  FDA 510(k) K073310 Active Cleared 18 Jan 2008

• Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; Sp-711 Sonoprobe System

  Class II

  FDA 510(k) K012239 Active Cleared 10 Aug 2001

• Eub-6000 Diagnostic Ultrasound Scanner Sp-711 Sonoprobe System

  Class II

  FDA 510(k) K011252 Active Cleared 30 May 2001

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