Data / Medical devices / Germany / 3C-Medical Intelligence GmbH
3C-Medical Intelligence GmbH: FDA-registered device maker in Landsberg am Lech Bavaria, Germany, 4 510(k) clearances
3C-Medical Intelligence GmbH is registered with the FDA (registration 9710332) in Landsberg am Lech Bavaria, Germany. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 4, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710332
- FEI number
- 3003251135
- Address
- 3C-Ring 1, Landsberg am Lech Bavaria, Germany, 86899
- Owner or operator
- 3C-Medical Intelligence GmbH (10082856)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 8, 2021
- Registered through
- 2026
- Brand names listed
- BlueBAG, BodyFIX, Fraxion, HexaPOD, INST 960-539 GUIDE BIOPSY, iBEAM, iGUIDE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Couch, Radiation Therapy, Powered | JAI | 2 | Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Contract manufacturer | accessdata.fda.gov |
| Table, Radiographic, Stationary Top | IXQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2015 | K143485 | iGuide 2.1 | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| June 20, 2012 | K121530 | BODYFIX SYSTEM | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| November 22, 2011 | K112210 | FRAXION | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| October 25, 2007 | K072898 | HEXAPOD EVO RT COUCH TOP | JAI | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 18, 2019 | 83358 | Class II | Terminated | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiothe | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Table, Radiographic, Stationary Top
- All makers of Neurological Stereotaxic Instrument
- All makers of Couch, Radiation Therapy, Powered
Updated March 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.