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Virtuoso System for Ihc Er (SP1) with Benchmark Ultra Stainer

by Ventana Medical Systems, Inc.

510(k) K140465

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140465 Date20 Mar 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0877-2021 FDA Class II initiated 23 Nov 2020

    When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.

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  • Withdrawn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

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