510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061613Substantially Equivalent

Ventana Image Analysis System - Pathway Her2 (4B5)

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

K061613 is the FDA 510(k) clearance record for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5), a class II device, cleared for Tripath Imaging on under FDA product code NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity). FDA's definition for product code NQN reads: "Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention". FDA records list 345 510(k) clearances for BECTON, DICKINSON & CO., from to . As of , FDA records show one recall naming K061613.

Clearance record

Decision date
Received
(215 days to decision)
Product code
NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Tripath Imaging 4025 Stirrup Creek Dr., Suite 400, Durham NC
510(k) summary
Statement
Third party review
No

Clearances, product code NQN

Trailing 12 months

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

FDA records show no clearances under product code NQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQN, 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