The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik-gmbh-an Elekta with the FDA for Modification To Hexapod Rt Couch Top.
| Device ID | K062639 |
| 510k Number | K062639 |
| Device Name: | MODIFICATION TO HEXAPOD RT COUCH TOP |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
| Contact | Michael Wolff |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 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 | 2006-09-06 |
| Decision Date | 2006-09-21 |
| Summary: | summary |