# MOT · Irradiator, Blood To Prevent Graft Versus Host Disease

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/RA-misc/MOT

## Overview

- **Product Code:** MOT
- **Device Name:** Irradiator, Blood To Prevent Graft Versus Host Disease
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K201177](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K201177.md) | RadGil2 | R3 X-Ray L.L.C | Aug 17, 2020 | SESE |
| [K181737](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K181737.md) | Raycell MK1 | Best Theratronics Limited | Jan 2, 2019 | SESE |
| [K172087](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K172087.md) | SANGRAY | Hitachi , Ltd. | Oct 27, 2017 | SESE |
| [K161324](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K161324.md) | Raycell Mk2 | Best Theratronics Limited | Aug 12, 2016 | SESE |
| [K082921](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K082921.md) | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Rad Source Technologies, Inc. | Feb 17, 2009 | SESE |
| [K051065](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K051065.md) | RAYCELL X-RAY BLOOD IRRADIATOR | Mds Nordion | May 26, 2005 | SESE |
| [K050963](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K050963.md) | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | Mds Nordion | May 20, 2005 | SESE |
| [K032684](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K032684.md) | RAYCELL | Mds Nordion | Sep 26, 2003 | SESE |
| [K974210](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K974210.md) | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Rad-Source, Inc. | Mar 30, 1998 | SESE |
| [K963497](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K963497.md) | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | Nordion International, Inc. | Nov 8, 1996 | SESE |
| [K952291](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K952291.md) | GAMMACELL 3000 ELAN | Nordion International, Inc. | Aug 25, 1995 | SESE |
| [K915767](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K915767.md) | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | J. L. Shepherd and Assoc. | Jul 12, 1995 | SESE |
| [K915766](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K915766.md) | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | J. L. Shepherd and Assoc. | Jul 12, 1995 | SESE |
| [K865027](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K865027.md) | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Cis-Us, Inc. | Feb 26, 1987 | SESE |
| [K851828](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K851828.md) | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | Sep 19, 1985 | SESE |
| [K837346](https://fda.innolitics.com/submissions/RA/RA-misc/MOT/K837346.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/RA/RA-misc/MOT](https://fda.innolitics.com/submissions/RA/RA-misc/MOT)

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