Digiray Corp.

Address:2F, 43, Munpyeongdong-ro,DAEJEON,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mirror, Mouth (EAX) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

FireCam HD Intraoral Camera - 08809466040610 Catalog Number :

Device Description : The advanced camera & optics technology of the FireCam HD IntraOral Camera enabl The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation.

Device Class : 1

Duns Number: 557815751

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : No

Device Count : 1

QuantorView - 08809466041112 Catalog Number :

Device Description : QuantorView is an image viewing software dedicated DICOM images produced by imag 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.

Device Class : 2

Duns Number: 557815751

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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