Modeification to Iplan Rt Dose

• 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-2251-2009 FDA Unclassified (pre-2012) ·initiated 12 Aug 2009

  Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.

1. 11 Jun 2008 Cleared FDA 510(k) K080888
2. 12 Aug 2009 Recall initiated FDA recalls Z-2251-2009
3. 19 Nov 2014 Recall initiated FDA recalls Z-0957-2015
4. 19 Nov 2014 Recall initiated FDA recalls Z-0956-2015

510(k) Number

K080888 ↗

FDA product code

MUJ

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

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

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

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• COHERENCE DOSIMETRIST, MODEL 2.2 by SIEMENS MEDICAL SOLUTIONS USA, INC.
• INTERPLANT by Burdette Medical Systems, Inc.
• syngo.via RT Image Suite by SIEMENS MEDICAL SOLUTIONS USA, INC.
• Prelude by Medcom GmbH
• MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM by Accuray, Inc.
• HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM by Helax AB
• RayCare 2024A SP4 by RaySearch Laboratories AB (PUBL)
• QuickPlan by Siris Medical
• STANDARD IMAGING E.IMRT CALCULATOR by STANDARD IMAGING INC.
• PROWESS PANTHER PROARC, MODEL VERSION 5.0 by Prowess, Inc.

• Automatic Registration

  Class II

  FDA 510(k) K234047 Active Cleared 20 Mar 2024

• RT Elements (4.0)

  Class II

  FDA 510(k) K223279 Active Cleared 14 Mar 2023

• ENT Em

  Class II

  FDA 510(k) K223734 Active Cleared 27 Apr 2023

• Z-Touch

  Class II

  FDA 510(k) K003268 Active Cleared 22 Feb 2001

See all devices from Brainlab AG →