Cytovision for Cep Xy

• • Terminated Z-2039-2016 FDA Class III ·initiated 2 May 2016 ·on shared 510(k) K042542

  Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.

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

510(k) Number

K042542 ↗

FDA Product Code

NTH

Device Class

Class II

Regulation

21 CFR Part 866.4700

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Ariol Her-2/Neu Fish

  Class II

  FDA 510(k) K043519 Active Cleared 25 Apr 2005

• Ariol

  Class II

  FDA 510(k) K033200 Active Cleared 18 Mar 2004

• Winscan Automated Imaging System

  Class II

  FDA 510(k) K980375 Active Cleared 9 Jun 1998

• Ariol Her-2/Neu Ihc

  Class II

  FDA 510(k) K031715 Active Cleared 8 Jan 2004

• Genevision - Computer Assisted Chromosome Karyo.

  Class II

  FDA 510(k) K902311 Active Cleared 20 Aug 1990

• Slidescan

  Class II

  FDA 510(k) K001420 Active Cleared 30 Aug 2000