The following data is part of a premarket notification filed by Doseoptics Llc with the FDA for Beamsite.
| Device ID | K212606 |
| 510k Number | K212606 |
| Device Name: | BeamSite |
| Classification | Accelerator, Linear, Medical |
| Applicant | DoseOptics LLC 16 Cavendish Ct Lebanon, NH 03766 |
| Contact | Venkat Krishnaswamy |
| Correspondent | Farzeen Christie DoseOptics LLC 16 Cavendish Ct Lebanon, NH 03766 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-17 |
| Decision Date | 2021-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009184503 | K212606 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BEAMSITE 97163877 not registered Live/Pending |
DoseOptics LLC 2021-12-09 |