Data / Medical devices / Denmark / Flexray Medical

Flexray Medical: FDA-registered device maker in Aalborg Nordjylland, Denmark, 7 510(k) clearances

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

Flexray Medical is registered with the FDA (registration 3014134519) in Aalborg Nordjylland, Denmark. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 24, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3014134519
Address: Speditorvej 19, Aalborg Nordjylland, Denmark, 9000
Owner or operator: FLEXRAY MEDICAL (10057092)
Roles: Exporter to the US
First device listed: January 5, 2022
Registered through: 2027
Brand names listed: BK 3000, Biograph mCT 64 FLOW, GE Discovery 710, Medtronic O-arm, Symbia T16

Devices it lists

Device	Product code	Class	Role	Source
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
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	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, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	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
April 24, 2020	K200074	O-arm O2 Imaging System	OWB	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
November 17, 2017	K173023	Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
July 17, 2015	K151486	Biograph mCT and mCT Flow PET/CT Scanners	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 21, 2014	K133657	DISCOVERY PET/CT 710	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 10, 2014	K132335	ULTRASOUND SCANNER FLEX FOCUS 1202	IYN	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov
August 30, 2013	K131576	OPTIMA CT660	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov

Compare with other makers

Updated April 24, 2020. 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.