MOT — Irradiator, Blood To Prevent Graft Versus Host Disease Class U
FDA Device Classification
Classification Details
- Product Code
- MOT
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K201177 | r3 x-ray l.l.c | RadGil2 | August 17, 2020 |
| K181737 | best theratronics limited | Raycell MK1 | January 2, 2019 |
| K172087 | hitachi | SANGRAY | October 27, 2017 |
| K161324 | best theratronics limited | Raycell Mk2 | August 12, 2016 |
| K082921 | rad source technologies | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | February 17, 2009 |
| K051065 | mds nordion | RAYCELL X-RAY BLOOD IRRADIATOR | May 26, 2005 |
| K050963 | mds nordion | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | May 20, 2005 |
| K032684 | mds nordion | RAYCELL | September 26, 2003 |
| K974210 | rad-source | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | March 30, 1998 |
| K963497 | nordion international | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | November 8, 1996 |
| K952291 | nordion international | GAMMACELL 3000 ELAN | August 25, 1995 |
| K915767 | j. l. shepherd and assoc | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | July 12, 1995 |
| K915766 | j. l. shepherd and assoc | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | July 12, 1995 |
| K865027 | cis-us | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | February 26, 1987 |
| K851828 | syncor intl | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | September 19, 1985 |
| K837346 | atomic energy of canada | MODEL GAMMACELL 1000 | June 24, 1983 |