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510(k) K101291

SCANVIEW HER2/NEU FISH SYSTEM by Applied Spectral Imaging , Ltd. — Product Code NTH

K101291 is an FDA 510(k) premarket notification submitted by Applied Spectral Imaging , Ltd. for the device "SCANVIEW HER2/NEU FISH SYSTEM". The FDA issued a decision of Substantially Equivalent on November 23, 2010. 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 Spectral Imaging , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2010
Date Received
May 7, 2010
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 Spectral Imaging , Ltd.

  • K140957 — GENASIS HIPATH IHC FAMILY (January 15, 2015)
  • K122554 — GENASIS SCANVIEW SYSTEM (February 7, 2013)
  • K110345 — SCANVIEW SYSTEM (October 19, 2011)
  • K071398 — SCANVIEW, MODEL SC-300 (October 4, 2007)
  • K050236 — FISHVIEW (June 27, 2005)
  • K012103 — BANDVIEW SYSTEM (September 14, 2001)
  • K973950 — RETINAL CUBE (December 12, 1997)

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)
  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)

FDA data resources