510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142965Substantially Equivalent

Virtuoso System for IHC PR (1E2) using iScan HT

Ventana Medical Systems Inc, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142965 is the FDA 510(k) clearance record for Virtuoso System for IHC PR (1E2) using iScan HT, a class II device, cleared for Ventana Medical Systems, Inc. on under FDA product code OEO (Automated Digital Image Manual Interpretation Microscope). FDA's definition for product code OEO reads: "The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic...". FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show no recalls naming K142965.

Clearance record

Decision date
Received
(275 days to decision)
Product code
OEO Automated Digital Image Manual Interpretation Microscope
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Ventana Medical Systems, Inc. 203 Ravendale Dr., Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEO

Trailing 12 months

FDA records hold no clearances under product code OEO in the trailing twelve months.

FDA records show no clearances under product code OEO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260