FDA.reportPublic FDA data

FireCR

Primary DI
08809466040016
Brand
FireCR
Company
Digiray Corp.
Model
FR01
Catalog number
CG-701
Device description
The FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Published
2016-06-20
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
08809466040016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809466040016088094660400168809466040016

GMDN Terms#

Term, Definition table
TermDefinition
Radiography digital imaging scannerA laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11.7Centimeter
Length70.3Centimeter
Weight30Kilogram
Width46.4Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82429312100esk@3DISCimaging.com

Regulatory Flags#

DUNS number
557815751
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809466040214FireCR DentalFR11CG-7022016-06-22
08809466040313FireCR SparkFR31CG-3012016-10-27
08809466040412FireCR FlashFR41CG-4012016-06-30
08809466040511FireCR SparkFR31CG-3012016-07-01
08809466041112QuantorView1.2.1.4662016-08-01
08809466040023Universal Cassette 35cmx43cm(IP 35cmx43cm)KitCA012016-08-02
08809466040030Universal Cassette 24cmx30cm(IP 24cmx30cm)KitCA022016-08-02
08809466040429Cassette 35cmx43cm(IP 35cmx43cm)KitCA042016-08-02
08809466040436Cassette 24cmx30cm(IP 24cmx30cm)KitCA052016-08-02
08809466040443Cassette 18cmx24cm(IP 18cmx24cm)KitCA062016-08-02
08809466040610FireCam HD Intraoral CameraFR612016-06-30

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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
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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
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D0031000086380SchickDentsply International Inc.MQB2024-11-06
D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06