FDA.reportPublic FDA data

Imagescan HD

Primary DI
08904269400583
Brand
Imagescan HD
Company
SKANRAY TECHNOLOGIES LIMITED
Model
303-001203-0
Device description
"Imagescan HD with 33"" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
Published
2020-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K170967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170967000Intraskan DC PlusSkanray Technologies Private Limited2017-06-08EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904269400583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904269400583089042694005838904269400583

GMDN Terms#

Term, Definition table
TermDefinition
Stationary intraoral dental x-ray system, digitalA 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 data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914-592-6100custserv@imageworkscorporation.com

Regulatory Flags#

DUNS number
863358955
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904269415105PodSKAN HF Diagnostic X-ray System303-002665-02023-12-22
18904269450783Star 60F3-86-390-0910-972019-05-24
18904269452053Star 90F3-99-390-0140-252019-09-27
18904269451520Skyline 55 wirelessF3-87-390-0074-492019-06-05
18904269451537Skyline 55 wirelessF3-87-390-0075-462019-06-05
18904269450769Star 60F3-86-390-0906-122019-05-24
18904269452046Star 90F3-99-390-0136-372019-05-22
18904269452886STAR 65F3-86-390-1000-212019-01-21
18904269450301Spotskan F3-85-390-0335-132019-05-24
18904269450318SPOTSKANF3-85-390-0336-102019-05-24
08904269409531SKANRAD 400303-000783-42022-05-11
08904269403522SKANMOBILE303-000018-32022-04-21
08904269403683SKANMOBILE DR303-000018-162022-04-21
08904269405519Skan C Mobile C - Arm X - Ray systemF303-000187-22019-01-21
08904269400460Intraskan DC Plus303-000134-262020-08-10
08904269400477Intraskan DC Plus303-000134-272020-08-10
08904269400521Rayos DC303-000134-802020-08-10
08904269400538Rayos DC303-000134-812020-08-10
08904269400545Rayos DC303-000134-822020-08-10
08904269400552Rayos DC303-000134-832020-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
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