FDA.reportPublic FDA data

Wireless Digital Flat Panel Detector(19 pin)

Primary DI
06970569090870
Brand
Wireless Digital Flat Panel Detector(19 pin)
Company
iRay Group
Model
Mars1717X
Device description
Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Published
2024-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970569090870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970569090870069705690908706970569090870

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421363780
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration 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
06970569091006Digital Radiographic Imaging Acquisition Software - DR (RiasDR)RiasDR2025-08-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
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06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
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08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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