Raycell MK1

FDA 510(k) K181737 · Best Theratronics Limited

Substantially Equivalent

510(k) numberK181737

Submission

Device name
Raycell MK1
Applicant
Best Theratronics Limited
Ottawa, CA
Received
July 2, 2018
Decision date
January 2, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOT – Irradiator, Blood To Prevent Graft Versus Host Disease
Device class
Unclassified

Other 510(k)s with product code MOT

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K201177RadGil2MOT · Traditional R3 X-Ray L.L.C08/17/2020SE
K172087SangrayMOT · Traditional Hitachi , Ltd.10/27/2017SE
K161324Raycell Mk2MOT · Special Best Theratronics Limited08/12/2016SE
K082921Rad Source X-Ray Blood Irradiator, Model RS-3400MOT · Traditional Rad Source Technologies, Inc.02/17/2009SE
K051065Raycell X-Ray Blood IrradiatorMOT · Special Mds Nordion05/26/2005SE
K050963Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special Mds Nordion05/20/2005SE
K032684RaycellMOT · Special Mds Nordion09/26/2003SE
K974210Shielded Cabinet X-Ray Radiation Source Device Model RS 3000MOT · Traditional Rad-Source, Inc.03/30/1998SE
K963497Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0MOT · Traditional Nordion International, Inc.11/08/1996SE
K952291Gammacell 3000 ElanMOT · Traditional Nordion International, Inc.08/25/1995SE

More from Nordion International, Inc.

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K161324Raycell Mk2MOT · Special 08/12/2016SE
K150191GammaBeam 500IWB · Traditional 04/17/2015SE
K142219GammaBeam 100IWB · Special 11/13/2014SE

Questions and answers

When was Raycell MK1 cleared by the FDA?

Raycell MK1 (K181737) received a 510(k) decision of Substantially Equivalent on January 2, 2019, 184 days after the submission was received.

What is the product code of K181737?

The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.