The following data is part of a premarket notification filed by Best Nomos with the FDA for Softdiso.
| Device ID | K170345 |
| 510k Number | K170345 |
| Device Name: | SOFTDISO |
| Classification | Accelerator, Linear, Medical |
| Applicant | Best Nomos 1 Best Drive Pittsburgh, PA 15202 |
| Contact | Vineet Gupta |
| Correspondent | Vineet Gupta Best Nomos 1 Best Drive Pittsburgh, PA 15202 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-03 |
| Decision Date | 2017-10-27 |
| Summary: | summary |