510(k) Report

FDA applicant

Medical Intelligence Medizintechnik-GmbH-An Elekta

Schwabmunchen, DE3 decisions2006–20075 recalls

FDA records 3 decisions for Medical Intelligence Medizintechnik-GmbH-An Elekta (Schwabmunchen, DE) from 2006 to 2007: 3 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JAI (Couch, Radiation Therapy, Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Medical Intelligence Medizintechnik-GmbH-An Elekta’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2019

2014: 12016: 22019: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Intelligence Medizintechnik-GmbH-An Elekta by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical2decisions
  • JAICouch, Radiation Therapy, Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072079Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 20071cites it
  • K062611Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 20061cites it

What has FDA decided for it lately?

  • K072079Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 20075 recalls
  • K062639Modification to Hexapod RT Couch TopMedical Intelligence Medizintechnik-GmbH-An Elekta · 2006
  • K062611Iguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta · 2006

All 3 as Medical Intelligence Medizintechnik-GmbH-An Elekta →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K072079IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator.…Jul 18, 2019Class II
  • K072079iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2Jun 19, 2019Class II
  • K072079HexaPOD evo RT System Product Usage: The intended use of the device is the control of…Aug 18, 2016Class II
  • K072079iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a…May 12, 2016Class II
  • K072079iGUIDE System Product Usage: The intended use of the device is the control of accurate…May 29, 2014Class II