Raycell X-Ray Blood Irradiator
FDA 510(k) K051065 · Mds Nordion
510(k) numberK051065
Submission
- Device name
- Raycell X-Ray Blood Irradiator
- Applicant
- Mds Nordion
Ottawa, CA - Received
- April 26, 2005
- Decision date
- May 26, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOT – Irradiator, Blood To Prevent Graft Versus Host Disease
- Device class
- Unclassified
Other 510(k)s with product code MOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201177 | RadGil2MOT · Traditional | R3 X-Ray L.L.C | 08/17/2020SE |
| K181737 | Raycell MK1MOT · Traditional | Best Theratronics Limited | 01/02/2019SE |
| K172087 | SangrayMOT · Traditional | Hitachi , Ltd. | 10/27/2017SE |
| K161324 | Raycell Mk2MOT · Special | Best Theratronics Limited | 08/12/2016SE |
| K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400MOT · Traditional | Rad Source Technologies, Inc. | 02/17/2009SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | Mds Nordion | 05/20/2005SE |
| K032684 | RaycellMOT · Special | Mds Nordion | 09/26/2003SE |
| K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000MOT · Traditional | Rad-Source, Inc. | 03/30/1998SE |
| K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0MOT · Traditional | Nordion International, Inc. | 11/08/1996SE |
| K952291 | Gammacell 3000 ElanMOT · Traditional | Nordion International, Inc. | 08/25/1995SE |
More from Nordion International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060870 | AvanzaJAI · Traditional | 05/15/2006SE |
| K053485 | Theratron Equinox, Models 80 CM and 100 CMIWB · Special | 03/09/2006SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | 05/20/2005SE |
| K032684 | RaycellMOT · Special | 09/26/2003SE |
| K020971 | DCM 2.0MUJ · Traditional | 06/06/2002SE |
| K010682 | Helax-Tms V 5.1 Radiation Therapy Treatment Planning SystemMUJ · Traditional | 06/05/2001SE |
| K011246 | DCM 1.0MUJ · Special | 05/23/2001SE |
| K001006 | Theratron 780C/1000 with Computerized Console UpgradeIWB · Special | 04/27/2000SE |
Questions and answers
When was Raycell X-Ray Blood Irradiator cleared by the FDA?
Raycell X-Ray Blood Irradiator (K051065) received a 510(k) decision of Substantially Equivalent on May 26, 2005, 30 days after the submission was received.
What is the product code of K051065?
The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.