510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051282Substantially Equivalent

Ventana Image Analysis System - Her2/neu

Becton Dickinson & Co, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051282 is the FDA 510(k) clearance record for VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU, a class II device, cleared for Tripath Imaging, 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 345 510(k) clearances for BECTON, DICKINSON & CO., from to . As of , FDA records show no recalls naming K051282.

Clearance record

Decision date
Received
(91 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
Tripath Imaging, Inc. 4025 Stirrup Creek Dr., Suite 400, Durham NC
510(k) summary
Statement
Third party review
No

Clearances, product code NOT

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