Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615832

FEI Number

3003026827

Entity Name

OWANDY RADIOLOGY

City/State/Country

CROISSY-BEAUBOURG Seine-et-Marne, FR

Establishment Address

2 Rue des vieilles vignes, Marne la Vallée, CROISSY-BEAUBOURG Seine-et-Marne 77183, FR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

OWANDY RADIOLOGY (Owner Number: 9042115)

Owner / Operator Contact Address

2 rue des vieilles vignes, --, CROISSY-BEAUBOURG, FR-77 77183, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231055

PMA Number

N/A

All Registered Proprietary Names

I-MAX 3D Opteo ONE Ow-RX NPR1000AA Owandy-CR I-MAX I-MAX Touch 3D Owandy-RX DC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-12-09
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-12-09
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-05-27
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2014-07-08
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2019-06-17
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-02-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2019-12-19
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-01-10

Official Correspondent

Eric FAUVARQUE

US Agent Details

Maria Denaro Email: operations@owandyus.com Phone: (516) 8585695

Related Public Records

Same Entity

OWANDY RADIOLOGY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3005383085	PALODEX GROUP OY	Tuusula Uusimaa, FI
3005843418	GENORAY CO., LTD.	Seongnam-si Gyeonggi, KR
3002819275	Alliage S/A Industrias Medico Odontologica	Ribeirao Preto Sao Paulo, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615832. Last updated year: 2026. Please use registration number 9615832 when referencing this establishment in official correspondence.