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Theratron-Phoenix

by Aecl Medical

510(k) K863180

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863180 Date27 Oct 1986ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1182-06 FDA Unclassified (pre-2012) initiated 8 Jul 2004

    The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

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  • Withdrawn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
IWB
Device Class
Class II
Regulation
21 CFR Part 892.5750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent