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510(k) K051282

VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU by Tripath Imaging, Inc. — Product Code NOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2005
Date Received
May 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Operator Intervention
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

Other clearances by Tripath Imaging, Inc.

  • K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (January 10, 2007)
  • K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (September 29, 2006)
  • K053520 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (April 11, 2006)
  • K050012 — VENTANA IMAGE ANALYSIS SYSTEM (May 6, 2005)

Other clearances for product code NOT

  • K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM (July 29, 2014)
  • K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (September 6, 2013)
  • K121350 — VIRTUSO SYSTEM FOR IHC (DO-7) (June 1, 2012)
  • K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (February 22, 2012)
  • K111543 — VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (October 12, 2011)
  • K080564 — SCANSCOPE XT SYSTEM (August 14, 2009)
  • K080910 — PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (February 4, 2009)
  • K071128 — SCANSCOPE XT SYSTEM (October 10, 2007)
  • K062756 — PATHIAM IMAGING SOFTWARE FOR HER2/NEU (February 20, 2007)
  • K031715 — ARIOL HER-2/NEU IHC (January 8, 2004)