Data / Medical devices / France / Owandy Radiology

Owandy Radiology: FDA-registered device maker in CROISSY-BEAUBOURG Seine-et-Marne, France, 9 510(k) clearances

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

Owandy Radiology is registered with the FDA (registration 9615832) in CROISSY-BEAUBOURG Seine-et-Marne, France. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 28, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9615832
FEI number: 3003026827
Address: 2 Rue des vieilles vignes Marne la Vallée, CROISSY-BEAUBOURG Seine-et-Marne, France, 77183
Owner or operator: OWANDY RADIOLOGY (9042115)
Roles: Repackager or relabeler
First device listed: May 27, 2014
Registered through: 2027
Brand names listed: I-MAX, I-MAX 3D, I-MAX Touch, I-MAX Touch 3D, NPR1000AA, ONE, Opteo, Ow-RX and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Surgical And Accessories	KQM	1	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Repackager or relabeler	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Repackager or relabeler	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
December 28, 2023	K231055	x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)	EHD	Substantially Equivalent	De Götzen S.R.L.	accessdata.fda.gov
February 5, 2021	K203374	X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)	MUH	Substantially Equivalent	De Götzen S.R.L.	accessdata.fda.gov
November 18, 2020	K201382	X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)	OAS	Substantially Equivalent	De Gotzen S.R.L.	accessdata.fda.gov
March 18, 2015	K143703	NICAL SMART MICRO CR system for intraoral dental images	MUH	Substantially Equivalent	Nical Spa	accessdata.fda.gov
May 30, 2014	K132378	X-MIND UNITY	EHD	Substantially Equivalent	De Gotzen S.R.L.	accessdata.fda.gov
April 28, 2014	K133271	OPTEO, VIDEOGRAPH HD	MUH	Substantially Equivalent	Owandy	accessdata.fda.gov
August 1, 2013	K130109	ENDOGRAPH DC	EHD	Substantially Equivalent	Villa Sistemi Medicali S.P.A.	accessdata.fda.gov
July 22, 2011	K111152	ROTOGRAPH EVO 3D	MUH	Substantially Equivalent	Villa Sistemi Medicali S.P.A.	accessdata.fda.gov
May 18, 2009	K090749	ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191	EHD	Substantially Equivalent	Villa Sistemi Medicali S.P.A.	accessdata.fda.gov

Compare with other makers

Updated December 28, 2023. 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.