FDA.reportPublic FDA data

OWANDY RADIOLOGY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96158323003026827OWANDY RADIOLOGY1N2027-01-012 Rue des vieilles vignes Marne la Vall�e CROISSY-BEAUBOURG Seine-et-Marne FR 77183

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
192931358548455K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)EHD2023-12-28
192931909542531K203374X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)MUH2021-02-05
192931977268795K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)OAS2020-11-18
192931875476515K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)OAS2018-11-02
192931753514097K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)MUH2017-07-06
192931759133687K143703NICAL SMART MICRO CR system for intraoral dental imagesMUH2015-03-18
192931092929285K133271OPTEO, VIDEOGRAPH HDMUH2014-04-28
192931423512990K132378X-MIND UNITYEHD2014-05-30
192931997996270K130109ENDOGRAPH DCEHD2013-08-01
192931758159671K111152ROTOGRAPH EVO 3DMUH2011-07-22
192931733375311K090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191EHD2009-05-18
192931591445467K030185ENDOS AC/ACPEHD2003-03-11
192931837342862

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EHD72023-12-28
MUH62021-02-05
OAS22020-11-18

GUDID#