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Adc Compact (Agfa Diagnostic Center)

by Bayer Corp., Agfa Div.

510(k) K974597

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974597 Date9 Mar 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0352-06 FDA Unclassified (pre-2012) initiated 18 Nov 2005

    Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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