The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Hexapod Rt Couchtop.
Device ID | K041448 |
510k Number | K041448 |
Device Name: | HEXAPOD RT COUCHTOP |
Classification | Couch, Radiation Therapy, Powered |
Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
Contact | Sandor Csaba Ats |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-06-01 |
Decision Date | 2004-06-16 |
Summary: | summary |