FDA.reportPublic FDA data

QuantorView

Primary DI
08809466041112
Brand
QuantorView
Company
Digiray Corp.
Model
1.2.1.466
Device description
QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration.
Published
2016-08-01
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151687000QuantorView3Disc Americas2015-08-03LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809466041112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809466041112088094660411128809466041112

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
0427103763kiwnd@digiray.co.kr

Regulatory Flags#

DUNS number
557815751
Device count
1
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
08809466040016FireCRFR01CG-7012016-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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