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510(k) K121516

VIRTUOSO SYSTEM FOR IHC HER2 (4B5) by Ventana Medical Systems, Inc. — Product Code NQN

K121516 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VIRTUOSO SYSTEM FOR IHC HER2 (4B5)". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity), a Class II device regulated under 21 CFR 864.1860. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
May 22, 2012
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 Ventana Medical Systems, Inc.

  • K242783 — Roche Digital Pathology Dx (December 17, 2024)
  • DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (December 5, 2024)
  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
  • K212176 — CINtec Histology (December 10, 2021)
  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)
  • DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests) (March 4, 2017)
  • K142965 — Virtuoso System for IHC PR (1E2) using iScan HT (July 16, 2015)
  • K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (March 20, 2014)
  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)

Other clearances for product code NQN

  • K140957 — GENASIS HIPATH IHC FAMILY (January 15, 2015)
  • K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (March 20, 2014)
  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 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)
  • K062428 — VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (September 29, 2006)

FDA data resources