The following data is part of a premarket notification filed by Best Theratronics Limited with the FDA for Raycell Mk2.
| Device ID | K161324 |
| 510k Number | K161324 |
| Device Name: | Raycell Mk2 |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| 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 | MOT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-08-12 |
| Summary: | summary |