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BodyFIX System

by Medical Intelligence Medizintechnik GmbH

510(k) K121530

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121530 Date20 Jun 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The BodyFIX System is a patient positioning and immobilization device designed for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery, and brachytherapy treatments of extracranial targets. The system comprises five principal components: a vacuum cushion, fixation sheet, vacuum supply, target positioner and localizer, and a carbon fiber baseplate.

The device is supplied as a complete system and is intended for single-use applications. It is not specified as reusable or sterilized. The system is not described as MRI safe. Storage requirements are not detailed in the provided data. The device received FDA 510(k) clearance on June 20, 2012, with a decision of Substantially Equivalent.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the BodyFIX System used for?

    The BodyFIX System is designed to immobilize patients for radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery, and brachytherapy treatments of extracranial targets.

  • Is the BodyFIX System reusable or sterilized?

    The BodyFIX System is intended for single-use applications and is not specified as reusable or sterilized.

  • What are the main components of the BodyFIX System?

    The system comprises five principal components: a vacuum cushion, fixation sheet, vacuum supply, target positioner and localizer, and a carbon fiber baseplate.

  • Does the BodyFIX System have FDA clearance?

    Yes, the BodyFIX System received FDA 510(k) clearance on June 20, 2012, with a decision of Substantially Equivalent.