BODYFIX— 510(k) K013391

Name: FDA 510(k) clearance K013391
Creator: U.S. Food and Drug Administration
Published: 2002-01-11

Substantially Equivalent

Medical Intelligence Medizintechnik GmbH

FDA 510(k) clearance K013391 for BODYFIX, Substantially Equivalent on 2002-01-11. Applicant: Medical Intelligence Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Medical Intelligence Medizintechnik GmbH
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2001-10-15
Decision date: 2002-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schwabmunchen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12
K253004 — LUNA 3D2026-06-04

More clearances from Medical Intelligence Medizintechnik GmbH

view all

K143485 — iGuide 2.12015-03-04
K121530 — BODYFIX SYSTEM2012-06-20
K112210 — FRAXION2011-11-22
K072898 — HEXAPOD EVO RT COUCH TOP2007-10-25
K071870 — HEXAPOD RT COUCH TOP2007-07-08

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.