The following data is part of a premarket notification filed by Best Theratronics Limited with the FDA for Gammabeam 500.
| Device ID | K150191 |
| 510k Number | K150191 |
| Device Name: | GammaBeam 500 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Best Theratronics Limited 413 March Road Ottawa, CA K2k 0e4 |
| Contact | Mike De Van Der Schueren |
| Correspondent | Mike De Van Der Schueren Best Theratronics Limited 413 March Road Ottawa, CA K2k 0e4 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-28 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014600076 | K150191 | 000 |
| 07540146000074 | K150191 | 000 |