Company ยท DE
Medical Intelligence Medizintechnik GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2015. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2015 | K143485 | iGuide 2.1 Medical Intelligence Medizintechnik GmbH, DE | IYE |
| Jun 20, 2012 | K121530 | BODYFIX SYSTEM Medical Intelligence Medizintechnik GmbH, DE | IYE |
| Nov 22, 2011 | K112210 | FRAXION Medical Intelligence Medizintechnik GmbH, DE | IYE |
| Oct 25, 2007 | K072898 | HEXAPOD EVO RT COUCH TOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| Jul 8, 2007 | K071870 | HEXAPOD RT COUCH TOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| Jun 16, 2004 | K041448 | HEXAPOD RT COUCHTOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| May 8, 2003 | K030439 | HEADFIX Medical Intelligence Medizintechnik GmbH | IYE |
| Jan 11, 2002 | K013391 | BODYFIX Medical Intelligence Medizintechnik GmbH, DE | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2019 | Medical Intelligence Medizintechnik Gmbh 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 Trackin Terminated |
IYE | K072079 |