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Forte

by Adac Laboratories

510(k) K982911

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982911 Date16 Nov 1998ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0216-2020 FDA Class I initiated 19 Sep 2019
    • Terminated Z-0213-2020 FDA Class I initiated 19 Sep 2019

    An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

    • Terminated Z-1774-2015 FDA Class II initiated 6 Mar 2015

    The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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