The following data is part of a premarket notification filed by R3 X-ray L.l.c with the FDA for Radgil2.
| Device ID | K201177 |
| 510k Number | K201177 |
| Device Name: | RadGil2 |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson, AZ 85716 |
| Contact | Robert Hase |
| Correspondent | Robert Hase R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson, AZ 85716 |
| 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 | 2020-05-01 |
| Decision Date | 2020-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B850033600040 | K201177 | 000 |