Skip to content

Ventana Image Analysis System, Model KI-67

by Tripath Imaging, Inc.

510(k) K053520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053520 Date11 Apr 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NQN
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ventana Image Analysis System, Model Ki-67 is an automated, computer-assisted image analysis system designed for immunohistochemistry. It is functionally connected to an interactive microscope to provide nuclear intensity and percent positivity analysis.

This device is regulated under FDA 510(k) clearance. It is classified as an automated image analysis microscope for use in hematology applications.

Other devices from Tripath Imaging, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Ventana Image Analysis System, Model Ki-67?

    This device is an automated, computer-assisted image analysis system designed for immunohistochemistry. It connects to an interactive microscope to perform nuclear intensity and percent positivity analysis.

  • What medical specialty is this system intended for?

    The system is classified as an automated image analysis microscope specifically intended for use in hematology applications.

  • What is the regulatory status of this device?

    The Ventana Image Analysis System, Model Ki-67 is regulated under FDA 510(k) clearance, having received a decision of substantial equivalence on April 11, 2006.