510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121350Substantially Equivalent

Virtuso System for Ihc (Do-7)

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

K121350 is the FDA 510(k) clearance record for VIRTUSO SYSTEM FOR IHC (DO-7), a class II device, cleared for Ventana Medical Systems, Inc. on under FDA product code NOT (Microscope, Automated, Image Analysis, Operator Intervention). FDA's definition for product code NOT reads: "Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention". FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show no recalls naming K121350.

Clearance record

Decision date
Received
(28 days to decision)
Product code
NOT Microscope, Automated, Image Analysis, Operator Intervention
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Ventana Medical Systems, Inc. 575 Shirlynn Ct., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOT

Trailing 12 months
1 clearance under product code NOT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NOT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260