The following data is part of a premarket notification filed by Dosisoft Sa with the FDA for Isogray Treatment Planning System.
| Device ID | K103146 |
| 510k Number | K103146 |
| Device Name: | ISOGRAY TREATMENT PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | DOSISOFT SA 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 -8489 |
| Contact | Robert J Morton |
| Correspondent | Robert J Morton DOSISOFT SA 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 -8489 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-03-11 |