Skip to content

Iplan Rt Dose

by Brainlab AG

510(k) K053584

Iplan Rt Dose is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Brainlab AG, cleared under FDA 510(k) K053584 on 12 Jul 2006, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK053584 Date12 Jul 2006ClearedStatusActive

Official records

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0957-2015 FDA Class II initiated 19 Nov 2014
    • Terminated Z-0956-2015 FDA Class II initiated 19 Nov 2014

    iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

    • Terminated Z-1010-2007 FDA Unclassified (pre-2012) initiated 5 Jun 2007 on shared 510(k) K053584

    Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K053584
  2. Recall initiated FDA recalls Z-1010-2007
  3. Recall initiated FDA recalls Z-0957-2015
  4. Recall initiated FDA recalls Z-0956-2015

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

Other devices from Brainlab AG

  • Automatic Registration

    Class II

  • RT Elements (4.0)

    Class II

  • ENT Em

    Class II

  • Z-Touch

    Class II

See all devices from Brainlab AG →