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
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26