The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Verisuite 1.8, Verisuite-particle 1.8, Verisuite, Verisuite-particle.
| Device ID | K133914 |
| 510k Number | K133914 |
| Device Name: | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | MEDCOM GMBH RUNDETURMSTRASSE 12 Darmstadt, DE 64283 |
| Contact | Luca Salvatore |
| Correspondent | Luca Salvatore MEDCOM GMBH RUNDETURMSTRASSE 12 Darmstadt, DE 64283 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260308110023 | K133914 | 000 |