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510(k) K042542

CYTOVISION FOR CEP XY by Applied Imaging Corp. — Product Code NTH

K042542 is an FDA 510(k) premarket notification submitted by Applied Imaging Corp. for the device "CYTOVISION FOR CEP XY". The FDA issued a decision of Substantially Equivalent on January 10, 2005. The device falls under product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays), a Class II device regulated under 21 CFR 866.4700. Applied Imaging Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2005
Date Received
September 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Device Class
Class II
Regulation Number
866.4700
Review Panel
PA
Submission Type

Other clearances by Applied Imaging Corp.

  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K033200 — ARIOL (March 18, 2004)
  • K031715 — ARIOL HER-2/NEU IHC (January 8, 2004)
  • K001420 — SLIDESCAN (August 30, 2000)
  • K980375 — WINSCAN AUTOMATED IMAGING SYSTEM (June 9, 1998)
  • K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (August 20, 1990)

Other clearances for product code NTH

  • K130775 — DUET SYSTEM (May 9, 2014)
  • K122554 — GENASIS SCANVIEW SYSTEM (February 7, 2013)
  • K110345 — SCANVIEW SYSTEM (October 19, 2011)
  • K101291 — SCANVIEW HER2/NEU FISH SYSTEM (November 23, 2010)
  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)

FDA data resources