The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Medcom Rt-viewer System.
| Device ID | K100056 |
| 510k Number | K100056 |
| Device Name: | MEDCOM RT-VIEWER SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | MEDCOM GMBH 12 RUNDETURMSTRASSE Darmstadt, Hessen, DE 64283 |
| Contact | Stefan Walter |
| Correspondent | Stefan Walter MEDCOM GMBH 12 RUNDETURMSTRASSE Darmstadt, Hessen, DE 64283 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-05-07 |