VATECH CO., LTD.

Address:13, Samsung 1-ro, 2-gil,Hwaseong-si Gyeonggi,KR

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Filters

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

System,X-Ray,Extraoral Source,Digital (MUH) (4) Unit, X-Ray, Extraoral With Timer (EHD) (4) X-Ray, Tomography, Computed, Dental (OAS) (2)

Premarket Exempt

Clear

Green 18 - 08800016400403 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Green 18 - 08800016400410 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Imag Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i Plus - 08800016400427 Catalog Number :

Device Description : Dental Digital X-ray Imaging System functioning Pano Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

PaX-i Plus - 08800016400434 Catalog Number :

Device Description : Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

PaX-i Insight - 08800016400441 Catalog Number :

Device Description : Dental Digital X-ray Imaging System functioning Pano Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

PaX-i Insight - 08800016400458 Catalog Number :

Device Description : Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

EzRay Air W - 08800016400465 Catalog Number :

Device Description : Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

EzRay Air W - 08800016400472 Catalog Number :

Device Description : Dental Extraoral Source X-ray System (Horizontal Arm Length 600mm)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

EzRay Air W - 08800016400489 Catalog Number :

Device Description : Dental Extraoral Source X-ray System (Horizontal Arm Length 450mm)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

EzRay Air - 08800016400496 Catalog Number :

Device Description : Dental Extraoral Source Portable X-ray System (SSD 200mm)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

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