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Gammamed 12I

by Mick Radio-Nuclear Instruments, Inc.

510(k) K891131

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK891131 Date7 Aug 1989ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0330-2012 FDA Unclassified (pre-2012) initiated 6 Oct 2011
    • Terminated Z-0329-2012 FDA Unclassified (pre-2012) initiated 6 Oct 2011

    The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.

    • Terminated Z-0486-2007 FDA Unclassified (pre-2012) initiated 11 Sep 2006

    Medical device for patient treatment does not meet electrical safety standards.

    • Terminated Z-1398-06 FDA Unclassified (pre-2012) initiated 1 May 2006

    Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.

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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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