Product code MOT
- Device name
- Irradiator, Blood To Prevent Graft Versus Host Disease
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201177 | RadGil2 | R3 X-Ray L.L.C | 2020-08-17 |
| K181737 | Raycell MK1 | Best Theratronics Limited | 2019-01-02 |
| K172087 | SANGRAY | Hitachi , Ltd. | 2017-10-27 |
| K161324 | Raycell Mk2 | Best Theratronics Limited | 2016-08-12 |
| K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Rad Source Technologies, Inc. | 2009-02-17 |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | Mds Nordion | 2005-05-26 |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | Mds Nordion | 2005-05-20 |
| K032684 | RAYCELL | Mds Nordion | 2003-09-26 |
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Rad-Source, Inc. | 1998-03-30 |
| K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | Nordion International, Inc. | 1996-11-08 |
| K952291 | GAMMACELL 3000 ELAN | Nordion International, Inc. | 1995-08-25 |
| K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 |
| K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Cis-Us, Inc. | 1987-02-26 |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | 1985-09-19 |
| K837346 | MODEL GAMMACELL 1000 | Atomic Energy of Canada | 1983-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B850033600040 | RADGIL2 | GILARDONI SPA | 2021-06-14 |
| 07540146000104 | Raycell | Best Theratronics Ltd | 2019-07-16 |
| 00754014600106 | Raycell | Best Theratronics Ltd | 2019-07-16 |
| 00860000737005 | RS | RAD SOURCE TECHNOLOGIES, INC. | 2019-03-29 |
| 07540146000012 | Gammacell | Best Theratronics Ltd | 2016-09-24 |
| 07540146000029 | Gammacell | Best Theratronics Ltd | 2016-09-24 |
| 07540146000043 | Raycell | Best Theratronics Ltd | 2016-09-24 |
| 00754014600014 | Gammacell | Best Theratronics Ltd | 2016-09-24 |
| 00754014600021 | Gammacell | Best Theratronics Ltd | 2016-09-24 |
| 00754014600045 | Raycell | Best Theratronics Ltd | 2016-09-24 |