# Iplan

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

- Canonical page: <https://devicerts.com/devices/iplan-haw-k053127>
- Manufacturer: [Brainlab AG](https://devicerts.com/manufacturers/brainlab-ag)
- Name in the registry: IPLAN
- Device class: Class II (US FDA)
- FDA product code: HAW

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The iPlan Performance is a planning and treatment transfer system for radiotherapy and neurosurgical applications, designed to facilitate precise treatment planning and adaptive radiotherapy workflows. It integrates advanced imaging, planning, and simulation tools to support complex treatment strategies, including stereotactic radiosurgery and fractionated radiotherapy. The system automates plan adjustments to accommodate anatomical changes, ensuring adaptive and dynamic treatment optimization. It is part of Brainlab’s iPlan suite, which emphasizes integration with existing clinical workflows and imaging modalities.

This system is supplied as software installed on a desktop platform, requiring compatible hardware and operating systems for operation. It is intended for use in radiation oncology departments and neurosurgical settings, where it interfaces with CT, MRI, and other imaging systems. The device is not single-use; it is designed for repeated use within a clinical environment, with updates and maintenance provided by the manufacturer. Regulatory clearance under FDA 510K (K053127) confirms its compliance with U.S. medical device standards, though specific sterility or MRI safety classifications are not detailed in the provided data.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K053127 · decision 2006-02-09 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K053127 [FDA 510(k)]
- FDA product code: HAW [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 882.4560 [FDA 510(k)]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Iplan, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/iplan-haw-k053127 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/iplan-haw-k053127.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-haw-k053127
- 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.