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510(k) K232879

Roche Digital Pathology Dx (VENTANA DP 200) by Ventana Medical Systems, Inc. — Product Code PSY

K232879 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "Roche Digital Pathology Dx (VENTANA DP 200)". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code PSY (Whole Slide Imaging System), a Class II device regulated under 21 CFR 864.3700. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2024
Date Received
September 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Slide Imaging System
Device Class
Class II
Regulation Number
864.3700
Review Panel
PA
Submission Type

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

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)
  • 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)
  • K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (September 26, 2013)

Other clearances for product code PSY

  • K251952 — Virasight (July 17, 2026)
  • K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system (July 15, 2026)
  • K243871 — Philips IntelliSite Pathology Solution 5.1 (March 6, 2025)
  • K241717 — E1000 Dx Digital Pathology Solution (February 28, 2025)
  • K242783 — Roche Digital Pathology Dx (December 17, 2024)
  • K242848 — Philips IntelliSite Pathology Solution 5.1 (December 10, 2024)
  • K241871 — Philips IntelliSite Pathology Solution (December 2, 2024)
  • K233204 — Philips IntelliSite Pathology Solution 5.1 (June 24, 2024)
  • K232833 — HALO AP Dx (May 7, 2024)
  • K232202 — Aperio GT 450 DX (April 16, 2024)

FDA data resources