K172087 is an FDA 510(k) clearance for the SANGRAY. This device is classified as a Irradiator, Blood To Prevent Graft Versus Host Disease.
Submitted by Hitachi , Ltd. (Kashiwa-Shi, JP). The FDA issued a Cleared decision on October 27, 2017, 108 days after receiving the submission on July 11, 2017.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K172087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2017 |
| Decision Date | October 27, 2017 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOT - Irradiator, Blood To Prevent Graft Versus Host Disease |
| Device Class | - |