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510(k) K080909

ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 by Ikonisys, Inc. — Product Code NTH

K080909 is an FDA 510(k) premarket notification submitted by Ikonisys, Inc. for the device "ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000". The FDA issued a decision of Substantially Equivalent on October 17, 2008. 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. Ikonisys, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2008
Date Received
April 1, 2008
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 Ikonisys, Inc.

  • K062755 — IKONISCOPE ONCOFISH BLADDER TEST SYSTEM (January 4, 2007)
  • K061392 — IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM (August 1, 2006)
  • K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM (January 24, 2006)

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)
  • 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