The following data is part of a premarket notification filed by Dosisoft Sa with the FDA for Epigray.
| Device ID | K112723 |
| 510k Number | K112723 |
| Device Name: | EPIGRAY |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | DOSISOFT SA 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
| Contact | Robert J Morton |
| Correspondent | Robert J Morton DOSLSOFT SA 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2012-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B501EPIGRAY020006 | K112723 | 000 |
| B501EPIGRAY020010 | K112723 | 000 |