The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Hexapod Rt Couch Top.
| Device ID | K071870 |
| 510k Number | K071870 |
| Device Name: | HEXAPOD RT COUCH TOP |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
| Contact | Michael Wolff |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2007-07-08 |
| Summary: | summary |