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510(k) K050012

VENTANA IMAGE ANALYSIS SYSTEM by Tripath Imaging, Inc. — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
January 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

Other clearances by Tripath Imaging, Inc.

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  • K053520 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (April 11, 2006)
  • K051282 — VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (August 16, 2005)

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  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)
  • K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (September 26, 2013)
  • K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (September 19, 2013)
  • K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (April 19, 2012)
  • K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2) (March 5, 2012)
  • K092333 — PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (October 27, 2010)
  • K073677 — SCANSCOPE XT SYSTEM (August 1, 2008)
  • K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (January 10, 2007)