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Model 3000 Nuclear Camera

by Ohio Imaging, Inc.

510(k) K882312

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 NumberK882312 Date14 Jul 1988ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0563-03 FDA Unclassified (pre-2012) initiated 23 Jan 2003 on shared 510(k) K882312

    The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
IYX
Device Class
Class I
Regulation
21 CFR Part 892.1100
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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