# Iplan Rt Dose

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

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

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K053584 · decision 2006-07-12 · 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-1010-2007 ·  · terminated · initiated 2007-06-05 · matched through shared submission K053584, may concern other models: 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.

## Identifiers

- 510(k) Number: K053584 [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: Iplan Rt Dose, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/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/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/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.