FDA.reportPublic FDA data

Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Primary DI
06970569091006
Brand
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
Company
iRay Group
Model
RiasDR
Device description
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970569091006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970569091006069705690910066970569091006

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421363780
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970569090993iRayiScan2026-01-13
06970569090856Digital Intraoral X-ray Imaging SystemXRI-301/2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemXRI-302/2025-08-29
06970569091020Wireless Digital Flat Panel DetectorDR10FW2025-06-11
06970569090931Mano4336A Wireless Digital Flat Panel DetectorMano4336A2025-05-13
06970569090948Mano4336F Wireless Digital Flat Panel DetectorMano4336F2025-05-13
06970569090955Mano4343A Wireless Digital Flat Panel DetectorMano4343A2025-05-13
06970569090962Mano4343F Wireless Digital Flat Panel DetectorMano4343F2025-05-13
06970569090979Mano2530A Wireless Digital Flat Panel DetectorMano2530A2025-05-13
06970569090986Mano2530F Wireless Digital Flat Panel DetectorMano2530F2025-05-13
06970569090009Digital flat panel detectorVenu1417C-PSI2016-10-12
06970569090016Digital flat panel detectorVenu1417C-VSI2016-10-12
06970569090023Digital flat panel detectorVenu1417P-PSI2016-10-12
06970569090030Digital flat panel detectorVenu1717M2016-10-12
06970569090047Wireless digital flat panel detectorMars1417V-PSI2016-10-12
06970569090054Wireless digital flat panel detectorMars1417V-TSI2016-10-12
06970569090894Digital Intraoral X-ray Imaging SystemPrime View Ultra 0/2024-10-25
06970569090900Digital Intraoral X-ray Imaging SystemPrime View Ultra 1/2024-10-25
06970569090917Digital Intraoral X-ray Imaging SystemPrime View Ultra 1.5/2024-10-25
06970569090924Digital Intraoral X-ray Imaging SystemPrime View Ultra 2/2024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28