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) (5) Unit, X-Ray, Extraoral With Timer (EHD) (3) System,X-Ray,Extraoral Source,Digital (MUH) (2)

Premarket Exempt

Clear

ProVecta S-Pan - 08800016400304 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

ProVecta S-Pan - 08800016400311 Catalog Number :

Device Description : Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

ProVecta HD - 08800016400328 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

ProVecta HD - 08800016400335 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

ProVecta HD - 08800016400342 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

PaX-i3D Green Premium / Green 21 - 08800016400359 Catalog Number :

Device Description : Dental Computed Tomography X-ray System intended to produce panoramic, cephalom Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data (Xmaru3104CF)

Device Class : 2

Duns Number: 689229516

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Green Smart - 08800016400366 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 Smart - 08800016400373 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

Green 16 - 08800016400380 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 16 - 08800016400397 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

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