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Protura Couch Software

by Med-Tec, Inc. D/B/A Civco Medical Solutions 2 variants

510(k) K132084

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132084 Date26 Sep 2013ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0671-2018 FDA Class II initiated 8 Nov 2017

    When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.

    • Terminated Z-1992-2016 FDA Class II initiated 31 Mar 2016

    When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting 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  • Withdrawn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
JAI
Device Class
Class II
Regulation
21 CFR Part 892.5770
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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