Skip to content

Headfix

by Medical Intelligence Medizintechnik GmbH

510(k) K030439

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 NumberK030439 Date8 May 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0538-2011 FDA Unclassified (pre-2012) initiated 14 Oct 2010

    The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Medical Intelligence Medizintechnik GmbH

  • Bodyfix

    Class II

  • BodyFIX System

    Class II

  • Fraxion

    Class II

  • Iguide System

    Class II

  • iGuide 2.1

    Class II

  • Hexapod Rt Couchtop

    Class II

See all devices from Medical Intelligence Medizintechnik GmbH →