SUNI MEDICAL IMAGING, INC.

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- Catalog Number : 400-1227-B

Device Description : The SuniRay2 Digital Radiography System is a semiconductor imaging device intend The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental radiography images in combination with a dedicated dental Imaging Software. The Digital Radiography System is available either with a #2 or #1 sensor size. It is intended to be used by dentists to diagnose dental diseases.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-1226-B

Device Description : The SuniRay2 Digital Radiography System is a semiconductor imaging device intend The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental radiography images in combination with a dedicated dental Imaging Software. The Digital Radiography System is available either with a #2 or #1 sensor size. It is intended to be used by dentists to diagnose dental diseases.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-1242S

Device Description : Digital Imaging software used with digital sensors to take x-ray images of teet Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-1243S

Device Description : Digital Imaging software used with digital sensors to take x-ray images of teet Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-1321

Device Description : The SuniIQ Digital Radiography System is a semiconductor imaging device intended The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real time intra-oral dental radiography images in combination with a dedicated dental X-ray source and imaging software. The digital radiography system is available either with a #1 size sensor or a #2 size sensor. It is intended to be used by dentists to diagnose dental diseases.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-1322

Device Description : The SuniIQ Digital Radiography System is a semiconductor imaging device intended The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real time intra-oral dental radiography images in combination with a dedicated dental X-ray source and imaging software. The digital radiography system is available either with a #1 size sensor or a #2 size sensor. It is intended to be used by dentists to diagnose dental diseases.

Device Class : 2

Duns Number: 180451106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1