Owandy Radiology

Primary DI
08057737126512
Brand
Owandy Radiology
Company
VILLA SISTEMI MEDICALI SPA
Model
Elios
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030185000ENDOS AC/ACPVilla Sistemi Medicali S.P.A.2003-03-11EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057737126512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057737126512080577371265128057737126512

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.

Regulatory Flags#

DUNS number
439173964
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057737122217Villa Sistemi MedicaliDRF 43432023-08-29
08057737122262Villa Sistemi MedicaliDRF 4343 FL2023-08-29
08057737122361Villa Sistemi MedicaliDRF 4343-TS2023-08-29
08057737120411Philips Medical Systems DMCJuno DRF2016-09-24
08057737125010Villa Sistemi MedicaliRotograph EVO2016-09-24
08057737125218Villa Sistemi MedicaliRotograph EVO D2016-09-24
08057737125416Villa Sistemi MedicaliRotograph EVO 3D2016-09-24
08057737126017Villa Sistemi MedicaliEndograph DC2016-09-24
08057737126215Villa Sistemi MedicaliEndos AC2016-09-24
08057737126413Villa Sistemi MedicaliEndos ACP2016-09-24
08057737126611Villa Sistemi MedicaliExplor-X AC2016-09-24
08057737126819Villa Sistemi MedicaliExplor-X ACP2016-09-24
08057737127212Villa Sistemi MedicaliVideograph HD94580001002016-09-24
08057737127229Villa Sistemi MedicaliVideograph HD94580002002016-09-24
08057737127311Villa Sistemi MedicaliVideograph94580003002016-09-24
08057737127328Villa Sistemi MedicaliVideograph94580004002016-09-24
08057737127410Polaroid - Miri Trading LLCKeren HD9458B001002016-09-24
08057737127427Polaroid - Miri Trading LLCKeren HD9458B002002016-09-24
08057737127519Polaroid - Miri Trading LLCKeren9458A001002016-09-24
08057737127526Polaroid - Miri Trading LLCKeren9458A002002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
00840326416020PanoramicYoung Innovations, Inc.EHD2022-12-22
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
D7641000064561Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10