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Oncentra, Oncentra External Beam, Oncentra Brachy

by Elekta Inc. D/B/A Nucletron Corporation

510(k) K121448

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK121448 Date2 Jul 2012ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0987-2017 FDA Class II initiated 23 Dec 2016

    Cross profile for Varian 60 degree wedge shows "horns."

    • Terminated Z-0604-2016 FDA Class II initiated 18 Dec 2015

    When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

    • Terminated Z-1712-2015 FDA Class II initiated 21 May 2015

    Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

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  • Withdrawn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