Data / Medical devices / Canada / ANDA Medical

ANDA Medical: FDA-registered device maker in Oshawa Ontario, Canada, 8 510(k) clearances

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

ANDA Medical is registered with the FDA (registration 3015223550) in Oshawa Ontario, Canada. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015223550
Address: 330 Marwood Dr. Unit 4, Oshawa Ontario, Canada, L1H 8B4
Owner or operator: ANDA Medical (10083854)
Roles: Exporter to the US
First device listed: December 23, 2021
Registered through: 2026
Brand names listed: CARESTREAM DRX REVOLUTION MOBILE XRAY SYSTEM, GE 1.5T Twinspeed MRI, GE Lightspeed VCT CT, GE OPTIMA XR 220AMX PORTABLE XRAY MACHINE, Gastroscope, OEC 9800 Plus C-Arm, Philips Veradius C-Arm, Siemens Arcadis Avantic C-Arm

Devices it lists

Device	Product code	Class	Role	Source
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Exporter to the US	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	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
March 11, 2026	K253185	Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System	IZL	Substantially Equivalent	Carestream Health	accessdata.fda.gov
September 25, 2014	K142383	Optima XR200amx, Optima XR220amx	IZL	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 10, 2014	K133819	VERADIUS	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
April 10, 2014	K131902	PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)	FDS	Substantially Equivalent	Pentax Medical Company	accessdata.fda.gov
October 8, 2008	K082761	GE LIGHTSPEED 7.2 CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 1, 2005	K051133	ARCADIS AVANTIC	OXO	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
April 17, 2002	K021049	OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM	OWB	Substantially Equivalent	Ge Oec Medical Systems	accessdata.fda.gov
August 3, 2001	K012200	1.5T INFINITY TWINSPEED MR SYSTEM	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov

Compare with other makers

Updated March 11, 2026. 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.