Irradiator, Blood To Prevent Graft Versus Host Disease
The Blood Irradiator to Prevent Graft Versus Host Disease is a radiology device used to irradiate blood products before transfusion, inactivating donor lymphocytes to prevent transfusion-associated graft-versus-host disease in immunocompromised patients. This device is currently unclassified by the FDA, meaning its regulatory pathway has not yet been definitively established. The product code is MOT, reviewed by the Radiology panel.
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Basic Information
- Product Code
- MOT
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201177 | RadGil2 | Aug 17, 2020 | Substantially Equivalent | R3 X-Ray L.L.C |
| K181737 | Raycell MK1 | Jan 02, 2019 | Substantially Equivalent | Best Theratronics Limited |
| K172087 | SANGRAY | Oct 27, 2017 | Substantially Equivalent | Hitachi , Ltd. |
| K161324 | Raycell Mk2 | Aug 12, 2016 | Substantially Equivalent | Best Theratronics Limited |
| K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Feb 17, 2009 | Substantially Equivalent | Rad Source Technologies, Inc. |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | May 26, 2005 | Substantially Equivalent | Mds Nordion |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | May 20, 2005 | Substantially Equivalent | Mds Nordion |
| K032684 | RAYCELL | Sep 26, 2003 | Substantially Equivalent | Mds Nordion |
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Mar 30, 1998 | Substantially Equivalent | Rad-Source, Inc. |
| K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | Nov 08, 1996 | Substantially Equivalent | Nordion International, Inc. |
| K952291 | GAMMACELL 3000 ELAN | Aug 25, 1995 | Substantially Equivalent | Nordion International, Inc. |
| K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | Jul 12, 1995 | Substantially Equivalent | J. L. Shepherd and Assoc. |
| K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | Jul 12, 1995 | Substantially Equivalent | J. L. Shepherd and Assoc. |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Feb 26, 1987 | Substantially Equivalent | Cis-Us, Inc. |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Sep 19, 1985 | Substantially Equivalent | Syncor Intl. Corp. |
| K837346 | MODEL GAMMACELL 1000 | Jun 24, 1983 | Substantially Equivalent | Atomic Energy of Canada |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.