The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Verisuite And Verisuite-particle, Version 1.8.
| Device ID | K092653 |
| 510k Number | K092653 |
| Device Name: | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| 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 | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2009-09-18 |
| Summary: | summary |