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Iplan

by Brainlab AG 3 variants

510(k) K053127

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Traditional NumberK053127 Date9 Feb 2006ClearedStatusActive

Official records

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  • Withdrawn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
HAW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code HAW (Neurological Stereotaxic Instrument).

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