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Lr 5200 Laser Film Recorder

by Bayer Corp., Agfa Div.

510(k) K964414

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 NumberK964414 Date27 Jan 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0207-04 FDA Unclassified (pre-2012) initiated 25 Nov 2003

    The GS1 circuit board may fail resulting in smoke or fire.

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  • Withdrawn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
LMC
Device Class
Class II
Regulation
21 CFR Part 892.2040
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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