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Best Theratronics Ltd.: FDA-registered device maker in Kanata Ontario, Canada, 9 510(k) clearances

Name: Best Theratronics Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Best Theratronics Ltd. is registered with the FDA (registration 3006946288) in Kanata Ontario, Canada. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 2, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006946288
Address: 413 March Road, Kanata Ontario, Canada, K2K 0E4
Owner or operator: BEST MEDICAL INTERNA (9001621)
Roles: Manufacturer
First device listed: February 19, 2008
Registered through: 2026
Brand names listed: Avanza, Equinox, GammaBeam 100-80, GammaBeam 500, Gammacell 1000 & 3000, MobileMosfet, Portable Dosimeter, Raycell Mk1 and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Couch, Radiation Therapy, Powered	JAI	2	Manufacturer	accessdata.fda.gov
Irradiator, Blood To Prevent Graft Versus Host Disease	MOT	U	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Radionuclide	IWB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 2, 2019	K181737	Raycell MK1	MOT	Substantially Equivalent	Best Theratronics Limited	accessdata.fda.gov
August 12, 2016	K161324	Raycell Mk2	MOT	Substantially Equivalent	Best Theratronics Limited	accessdata.fda.gov
April 17, 2015	K150191	GammaBeam 500	IWB	Substantially Equivalent	Best Theratronics Limited	accessdata.fda.gov
November 13, 2014	K142219	GammaBeam 100	IWB	Substantially Equivalent	Best Theratronics Limited	accessdata.fda.gov
August 28, 2009	K092285	PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90	IYE	Substantially Equivalent	Best Medical Canada , Ltd.	accessdata.fda.gov
May 15, 2006	K060870	AVANZA	JAI	Substantially Equivalent	Mds Nordion	accessdata.fda.gov
March 9, 2006	K053485	THERATRON EQUINOX, MODELS 80 CM AND 100 CM	IWB	Substantially Equivalent	Mds Nordion, Inc.	accessdata.fda.gov
May 20, 2005	K050963	GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN	MOT	Substantially Equivalent	Mds Nordion	accessdata.fda.gov
June 25, 2004	K041557	MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W	IYE	Substantially Equivalent	Thomson & Nielsen Electronics, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 6, 2016	74637	Class II	Terminated	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 Host Disease.	It was discovered that both the new device and the predicate device failed to comply with performance standard.	accessdata.fda.gov

Compare with other makers

Updated January 2, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.