FDA.reportPublic FDA data

Owandy Radiology

Primary DI
03760262650616
Brand
Owandy Radiology
Company
OWANDY RADIOLOGY
Model
Ow-RX
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262650616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262650616037602626506163760262650616

GMDN Terms#

Term, Definition table
TermDefinition
Stationary intraoral dental x-ray system, analogueA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The image is from film or phosphor plate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
265612235
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760262653006Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 80 (16” - 40,64cm)5.92.156022025-09-05
03760262653013Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)5.92.156032025-09-05
03760262653020Owandy-RX DCDC OWANDY 115V,SHORT CONE,MOBILE5.92.156042025-09-05
03760262653044Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 40 (16” - 40,645.92.156062025-09-05
03760262653051Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 80 (16” - 40,645.92.156072025-09-05
03760262653068Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 110 (16” - 40,65.92.156082025-09-05
03760262653075Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,MOBILE5.92.156092025-09-05
03760262653327Owandy-RX DCDC OWANDY 115V,SHORT CONE,NO BRACKET,NO WALL PLATE5.92.156852025-09-05
03760262653334Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,NO BRACKET,NO WALL P5.92.156902025-09-05
03760262653372Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 40 (16” - 40,64cm)5.92.156102025-09-05
03760262653389Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 80 (16” - 40,64cm)5.92.156112025-09-05
03760262653396Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 110 (16” - 40,64cm)5.92.156122025-09-05
03760262653402Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 40 (16” - 40,64c5.92.156132025-09-05
03760262653419Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 80 (16” - 40,64c5.92.156142025-09-05
03760262653426Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 110 (16” - 40,645.92.156152025-09-05
03760262652993Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 40 (16” - 40,64cm)5.92.156012025-09-04
03760262650814Owandy RadiologyOWANDY OPTEO SIZE 1.594581001502025-05-15
03760262651606I-MAXI-MAX PAN ONLY FLOOR 100-120V9304000011.FL2024-11-11
03760262651804I-MAX 3DI-MAX 3D PAN ONLY FLOOR 100-120V9304100011.FL2024-11-11
03760262650630Owandy-RX PROOWANDY-RX PRO TOP 40 SHORT CONE, INTERF WALL PLATEW08060002022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
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D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10