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Medical Intelligence Medizintechnik GmbH

Also registered as Medical Intelligence Medizintechnik-GmbH-An Elekta

Country not established

Devices
11
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Medical Intelligence Medizintechnik GmbH makes

Medical Intelligence Medizintechnik GmbH manufactures medical devices including BODYFIX, BODYFIX SYSTEM, HEADFIX, FRAXION, iGuide 2.1, HEXAPOD RT COUCHTOP, HEXAPOD RT COUCH TOP, and HEXAPOD EVO RT COUCH TOP, which appear to be immobilization and positioning systems for radiation therapy and medical procedures.

The company's devices are listed in the FDA 510(k) registry and are classified as Class II, indicating they require special controls for safety and effectiveness. Medical Intelligence Medizintechnik GmbH is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Bodyfix Ref K013391

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bodyfix System Ref K121530

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Headfix Ref K030439

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fraxion Ref K112210

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Iguide System Ref K062611

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • iGuide 2.1 Ref K143485

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexapod Rt Couchtop Ref K041448

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Hexapod Rt Couch Top Ref K062639

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexapod Rt Couch Top Ref K071870

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Iguide System Ref K072079

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hexapod Evo Rt Couch Top Ref K072898

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Medical Intelligence Medizintechnik GmbH, initiated on 2019-07-18. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2019

    • 18 Jul 2019 Z-2082-2019 Class II Terminated Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan. Distribution: Worldwide Distribution - US Nationwide Submission number: K072079

Frequently asked questions

How many devices does Medical Intelligence Medizintechnik GmbH have in the registry?

The registry currently lists 11 devices for Medical Intelligence Medizintechnik GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medical Intelligence Medizintechnik GmbH's devices?

Among its 11 most recently registered devices, Medical Intelligence Medizintechnik GmbH has devices listed in FDA 510(k) (11 devices).

What risk classes do Medical Intelligence Medizintechnik GmbH's devices fall under?

Among its 11 most recently registered devices, the classes recorded for Medical Intelligence Medizintechnik GmbH's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Medical Intelligence Medizintechnik GmbH?

FDA recall records list 1 recall initiated by Medical Intelligence Medizintechnik GmbH, the most recent initiated on 18 Jul 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Medical Intelligence Medizintechnik GmbH in the registry?

The most recently registered devices listed for Medical Intelligence Medizintechnik GmbH include BODYFIX, BODYFIX SYSTEM, HEADFIX and FRAXION.

Generated automatically from registry data and not verified by a human reviewer.