FDA.reportPublic FDA data

X3C 1600 Plus Digital Radiographic System

Primary DI
00823073041028
Brand
X3C 1600 Plus Digital Radiographic System
Company
Imaging Dynamics Company Ltd
Model
1600 X3C
Device description
Digital Radiographic System
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
KPRSystem, x-ray, stationary
MQBSolid state x-ray imager (flat panel/digital imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00823073041028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00823073041028008230730410288230730410280823073041028

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Height2645Millimeter
Length2450Millimeter
Weight324Kilogram
Width1550Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius40 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
00823073004016Flat Panel Fixed/Portable SystemInnovaXion2017-01-26
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
08056600520051Nical Flat PanelNICAL SPAMQB2023-10-09
08057737122217Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29
08057737122262Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
08436046002388SEDECALSEDECALMQB2020-11-20
08436046002517SEDECALSEDECALMQB2020-05-29
08436046002456SEDECALSEDECALMQB2019-11-30
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121259FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121266FDR ClinicaDRGEM CorporationKPR2019-11-20