FDA.reportPublic FDA data

Flat Panel Fixed/Portable System

Primary DI
00823073004016
Brand
Flat Panel Fixed/Portable System
Company
Imaging Dynamics Company Ltd
Model
InnovaXion
Device description
Flat Panel Detector
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00823073004016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00823073004016008230730040168230730040160823073004016

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length480Millimeter
Weight3.8Kilogram
Width491Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(403)251-9939info@imagingdynamics.com

Regulatory Flags#

DUNS number
252909973
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00823073002111Aquarius 86001717TC2018-11-23
00823073003217Aquarius 86001417WC2018-11-27
00823073005112Aquarius 86001717WCI2018-11-28
00823073005211Aquarius 86001417WCI2018-11-28
00823073001015Xplorer 1000 Detector Head (X4C)X4C2017-01-26
00823073001022X3C Detector HeadX3C2017-01-26
00823073001039Xaminer Detector HeadX3C2017-01-26
00823073001046X3G Detector HeadX3G2017-01-26
00823073011014Xplorer 1100 Digital Radiographic System1100 X4C2017-01-26
00823073011021X3C 1100 Digital Radiographic System1100 X3C2017-01-26
00823073021013Xplorer 1500 Digital Radiographic System1500 X4C2017-01-26
00823073021020X3C 1590 Digital Radiographic System1590 X3C2017-01-26
00823073031012Xplorer 1590 Digital Radiographic System1590 X4C2017-01-26
00823073031029X3C 1600 Digital Radiographic System1600 X3C2017-01-26
00823073041011Xplorer 1600 Digital Radiographic System1600 X4C2017-01-26
00823073041028X3C 1600 Plus Digital Radiographic System1600 X3C2017-01-26
00823073051010Xplorer 1600 Plus Digital Radiographic System1600 X4C2017-01-26
00823073051027X3C 2200 Digital Radiographic System2200 X3C2017-01-26
00823073061018Xplorer 2200 Digital Radiographic System2200 X4C2017-01-26
00823073061019Xplorer 1800 Digital Radiographic System1800 X4C2017-01-26

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Primary DI, Brand, Company table
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08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00810035220546Radmedix AcuityDRe 1717tRADMEDIX, LLCMQB2025-10-28
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
D0031000082900SchickDentsply International Inc.MQB2024-11-06
D0031000085860SchickDentsply International Inc.MQB2024-11-06
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D0031000086350SchickDentsply International Inc.MQB2024-11-06
D0031000086360SchickDentsply International Inc.MQB2024-11-06
D0031000086380SchickDentsply International Inc.MQB2024-11-06
D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06