The following data is part of a premarket notification filed by Best Theratronics Limited with the FDA for Raycell Mk1.
| Device ID | K181737 |
| 510k Number | K181737 |
| Device Name: | Raycell MK1 |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | Best Theratronics Limited 413 March Road Ottawa, CA K2k 0e4 |
| Contact | Mojgan Soleimani |
| Correspondent | Mojgan Soleimani 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014600106 | K181737 | 000 |
| 07540146000104 | K181737 | 000 |