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Hexapod Evo Rt Couch Top

by Medical Intelligence Medizintechnik GmbH

510(k) K072898

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Special NumberK072898 Date25 Oct 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2535-2018 FDA Class II initiated 16 May 2018

    Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

    • Terminated Z-1514-2014 FDA Class II initiated 17 Apr 2014

    If screws are not properly tightened with a torque wrench they may become loose over time.

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  • Withdrawn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
JAI
Device Class
Class II
Regulation
21 CFR Part 892.5770
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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