MOT · Irradiator, Blood To Prevent Graft Versus Host Disease
· Class U
Overview
| Product Code | MOT |
|---|---|
| Device Name | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201177 | RadGil2 | R3 X-Ray L.L.C | Aug 17, 2020 | SESE |
| K181737 | Raycell MK1 | Best Theratronics Limited | Jan 2, 2019 | SESE |
| K172087 | SANGRAY | Hitachi , Ltd. | Oct 27, 2017 | SESE |
| K161324 | Raycell Mk2 | Best Theratronics Limited | Aug 12, 2016 | SESE |
| K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Rad Source Technologies, Inc. | Feb 17, 2009 | SESE |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | Mds Nordion | May 26, 2005 | SESE |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | Mds Nordion | May 20, 2005 | SESE |
| K032684 | RAYCELL | Mds Nordion | Sep 26, 2003 | SESE |
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Rad-Source, Inc. | Mar 30, 1998 | SESE |
| K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | Nordion International, Inc. | Nov 8, 1996 | SESE |
| K952291 | GAMMACELL 3000 ELAN | Nordion International, Inc. | Aug 25, 1995 | SESE |
| K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | J. L. Shepherd and Assoc. | Jul 12, 1995 | SESE |
| K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | J. L. Shepherd and Assoc. | Jul 12, 1995 | SESE |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Cis-Us, Inc. | Feb 26, 1987 | SESE |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | Sep 19, 1985 | SESE |
| K837346 | MODEL GAMMACELL 1000 | Atomic Energy of Canada | Jun 24, 1983 | SESE |
Top Applicants
- Mds Nordion — 3 clearances
- Best Theratronics Limited — 2 clearances
- J. L. Shepherd and Assoc. — 2 clearances
- Nordion International, Inc. — 2 clearances
- Atomic Energy of Canada — 1 clearance
