ClearanceBrief
Company ยท CA

Best Theratronics Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2019. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MOTIrradiator, Blood To Prevent Graft Versus Host Disease3
IWBSystem, Radiation Therapy, Radionuclide2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 2, 2019K181737Raycell MK1
Best Theratronics Limited, CA
MOT
Aug 12, 2016K161324Raycell Mk2
Best Theratronics Limited, CA
MOT
Apr 17, 2015K150191GammaBeam 500
Best Theratronics Limited, CA
IWB
Nov 13, 2014K142219GammaBeam 100
Best Theratronics Limited, CA
IWB

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 22, 2016BEST THERATRONICS LTD.
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Ho
Terminated		 MOTNone listed
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