Rayence Co., Ltd.

Address:14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil,Hwaseong-si Gyeonggi,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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (7) System, Image Processing, Radiological (LLZ) (2) System,X-Ray,Extraoral Source,Digital (MUH) (1)

Premarket Exempt

No Yes

Clear

1417WCA - 08800018600306 Catalog Number :

Device Description : 1417WCA is a digital X-ray flat panel detector that can acquire radiographic ima 1417WCA is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

910SGA - 08800018600313 Catalog Number :

Device Description : 910SGA is a digital solid state X-ray detector that is based on flat-panel techn 910SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

1717G - 08800018600320 Catalog Number :

Device Description : 1717G is an X-ray image acquisition device that is based on flat-panel. This dev 1717G is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and anX-ray generator.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

1417WGC - 08800018600337 Catalog Number :

Device Description : 1417WGC is a digital X-ray flat panel detector that can generate images of any p 1417WGC is a digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

1417WCC - 08800018600344 Catalog Number :

Device Description : 1417WCC is a digital X-ray flat panel detector that can generate images of any p 1417WCC is a digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

1717SGN - 08800018600351 Catalog Number :

Device Description : 1717SGN is an X-ray image acquisition device that is based on flat-panel. This d 1717SGN is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

1717SCN - 08800018600368 Catalog Number :

Device Description : 1717SCN is an X-ray image acquisition device that is based on flat-panel. This d 1717SCN is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

XmaruView V1 - 08800018600399 Catalog Number :

Device Description : XmaruView V1 is a radiographic image acquisition and image data management progr XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xmaru PACS - 08800018600429 Catalog Number :

Device Description : Xmaru PACS is a software program designed to provide image acquisition, processi Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

HDI-P - 08800018600436 Catalog Number :

Device Description : Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral i Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.

Device Class : 2

Duns Number: 557804458

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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