# Modeification to Iplan Rt Dose

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj>
- Manufacturer: [Brainlab AG](https://devicerts.com/manufacturers/brainlab-ag)
- Name in the registry: MODEIFICATION TO IPLAN RT DOSE
- Device class: Class II (US FDA)
- FDA product code: MUJ

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K080888 · decision 2008-06-11 · decision SESE · status: Active

## Recalls

- Z-0957-2015 · Class II · terminated · initiated 2014-11-19: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
- Z-0956-2015 · Class II · terminated · initiated 2014-11-19: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
- Z-2251-2009 ·  · terminated · initiated 2009-08-12: 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.

## Identifiers

- 510(k) Number: K080888 [FDA 510(k)]
- FDA product code: MUJ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.5050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Modeification to Iplan Rt Dose, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.