Shielded Cabinet X-Ray Radiation Source Device Model RS 3000
FDA 510(k) K974210 · Rad-Source, Inc.
510(k) numberK974210
Submission
- Device name
- Shielded Cabinet X-Ray Radiation Source Device Model RS 3000
- Applicant
- Rad-Source, Inc.
Coral Springs, FL, US - Received
- November 10, 1997
- Decision date
- March 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K051065 | Raycell X-Ray Blood IrradiatorMOT · Special | Mds Nordion | 05/26/2005SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | Mds Nordion | 05/20/2005SE |
| K032684 | RaycellMOT · Special | Mds Nordion | 09/26/2003SE |
| 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 |
Questions and answers
When was Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 cleared by the FDA?
Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 (K974210) received a 510(k) decision of Substantially Equivalent on March 30, 1998, 140 days after the submission was received.
What is the product code of K974210?
The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.