Raycell Mk2

FDA 510(k) K161324 · Best Theratronics Limited

Substantially Equivalent

510(k) numberK161324

Submission

Device name
Raycell Mk2
Applicant
Best Theratronics Limited
Ottawa, CA
Received
May 11, 2016
Decision date
August 12, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 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

510(k)DeviceApplicantDecision
K201177RadGil2MOT · Traditional R3 X-Ray L.L.C08/17/2020SE
K181737Raycell MK1MOT · Traditional Best Theratronics Limited01/02/2019SE
K172087SangrayMOT · Traditional Hitachi , Ltd.10/27/2017SE
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.

510(k)DeviceDecision
K181737Raycell MK1MOT · Traditional 01/02/2019SE
K150191GammaBeam 500IWB · Traditional 04/17/2015SE
K142219GammaBeam 100IWB · Special 11/13/2014SE

Questions and answers

When was Raycell Mk2 cleared by the FDA?

Raycell Mk2 (K161324) received a 510(k) decision of Substantially Equivalent on August 12, 2016, 93 days after the submission was received.

What is the product code of K161324?

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