Mycolor 202 Diagnostic Ultrasound System and Transducers

• 2 recalls, same reason

  • Terminated Z-0523-2009 FDA Unclassified (pre-2012) ·initiated 12 Aug 2008
  • Terminated Z-0522-2009 FDA Unclassified (pre-2012) ·initiated 12 Aug 2008

  The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.

• 3 recalls, same reason

  • Terminated Z-2014-2008 FDA Unclassified (pre-2012) ·initiated 29 May 2008
  • Terminated Z-2013-2008 FDA Unclassified (pre-2012) ·initiated 29 May 2008
  • Terminated Z-2015-2008 FDA Unclassified (pre-2012) ·initiated 29 May 2008

  HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

510(k) Number

K031552 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• SA8800 Diagnostic Ultrasound System and Transducers,

  Class II

  FDA 510(k) K974269 Active Cleared 21 Aug 1998

• Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound System and Transducers

  Class II

  FDA 510(k) K990970 Active Cleared 7 Apr 1999

• Sonoace 600 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K000030 Active Cleared 19 Jan 2000

• SA 9900 Plus Diagnostic Ultrasound System

  Class II

  FDA 510(k) K032329 Active Cleared 6 Aug 2003

• Sonoace SA-8000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K013627 Active Cleared 16 Nov 2001

• Combison 530 Diagnostic Ultrasound Scanner

  Class II

  FDA 510(k) K940942 Active Cleared 19 Feb 1997

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