Medical Intelligence Medizintechnik Gmbh
FDA Regulatory Profile
Medical Intelligence Medizintechnik Gmbh appears in FDA public data with 1 recall, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2082-2019, Class II) was initiated on July 18, 2019. Its most recent 510(k) clearance was granted on March 4, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2082-2019 | Class II | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The i | July 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K143485 | iGuide 2.1 | March 4, 2015 |
| K121530 | BODYFIX SYSTEM | June 20, 2012 |
| K112210 | FRAXION | November 22, 2011 |
| K072898 | HEXAPOD EVO RT COUCH TOP | October 25, 2007 |
| K071870 | HEXAPOD RT COUCH TOP | July 8, 2007 |
| K041448 | HEXAPOD RT COUCHTOP | June 16, 2004 |
| K030439 | HEADFIX | May 8, 2003 |
| K013391 | BODYFIX | January 11, 2002 |