| Device Type ID | 5439 |
| Device Name | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MOT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5439 |
| Device | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Product Code | MOT |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HITACHI LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BEST THERATRONICS LTD. | II | Jul-22-2016 |