The following data is part of a premarket notification filed by Hitachi Ltd. with the FDA for Sangray.
| Device ID | K172087 |
| 510k Number | K172087 |
| Device Name: | SANGRAY |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | Hitachi Ltd. 2-1, Shintoyofuta Kashiwa-shi, JP 277-0804 |
| Contact | Kazuaki Tsuchiya |
| Correspondent | Takahiro Haruyama Globizz Corporation 1411 W. 190th St. Suite 200 Gardena, CA 90248 |
| 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 | 2017-07-11 |
| Decision Date | 2017-10-27 |
| Summary: | summary |