Product code MOT ยท Class U
Irradiator, Blood To Prevent Graft Versus Host Disease
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in MOT
| Company | 510(k)s | Recalls |
|---|---|---|
| Best Theratronics Limited | 2 | 1 |
| Mds Nordion | 3 | 0 |
| J. L. Shepherd and Assoc. | 2 | 0 |
| Nordion International, Inc. | 2 | 0 |
| Rad Source Technologies, Inc. | 1 | 1 |
| Atomic Energy of Canada | 1 | 0 |
| Cis-Us, Inc. | 1 | 0 |
| Hitachi , Ltd. | 1 | 0 |
| R3 X-Ray L.L.C | 1 | 0 |
| Rad-Source, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2020 | K201177 | RadGil2 R3 X-Ray L.L.C | MOT |
| Jan 2, 2019 | K181737 | Raycell MK1 Best Theratronics Limited, CA | MOT |
| Oct 27, 2017 | K172087 | SANGRAY Hitachi , Ltd., JP | MOT |
| Aug 12, 2016 | K161324 | Raycell Mk2 Best Theratronics Limited, CA | MOT |
| Feb 17, 2009 | K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 Rad Source Technologies, Inc. | MOT |
| May 26, 2005 | K051065 | RAYCELL X-RAY BLOOD IRRADIATOR Mds Nordion, CA | MOT |
| May 20, 2005 | K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN Mds Nordion, CA | MOT |
| Sep 26, 2003 | K032684 | RAYCELL Mds Nordion, CA | MOT |
| Mar 30, 1998 | K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 Rad-Source, Inc. | MOT |
| Nov 8, 1996 | K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 Nordion International, Inc., CA | MOT |
| Aug 25, 1995 | K952291 | GAMMACELL 3000 ELAN Nordion International, Inc. | MOT |
| Jul 12, 1995 | K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS J. L. Shepherd and Assoc. | MOT |
| Jul 12, 1995 | K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS J. L. Shepherd and Assoc. | MOT |
| Feb 26, 1987 | K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C Cis-Us, Inc. | MOT |
| Sep 19, 1985 | K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C Syncor Intl. Corp. | MOT |
| Jun 24, 1983 | K837346 | MODEL GAMMACELL 1000 Atomic Energy of Canada, CA | MOT |
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