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

X-Ray, Tomography, Computed, Dental (OAS) (6) System,X-Ray,Extraoral Source,Digital (MUH) (4)

Premarket Exempt

Clear

PaX-i3D - 08800016400205 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i3D - 08800016400212 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i3D - 08800016400229 Catalog Number :

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

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i3D - 08800016400236 Catalog Number :

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

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i3D - 08800016400243 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i3D - 08800016400250 Catalog Number :

Device Description : Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

PaX-i - 08800016400267 Catalog Number :

Device Description : Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

PaX-i - 08800016400274 Catalog Number :

Device Description : 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 - 08800016400281 Catalog Number :

Device Description : Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisit

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

PaX-i - 08800016400298 Catalog Number :

Device Description : Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisit

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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