PaX-i3D Smart

GUDID 08800016400014

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1404CF / Xmaru2301CF)

VATECH CO., LTD.

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08800016400014
NIH Device Record Keyfd217d02-23ed-4e92-bd1f-b55f9a569fcb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaX-i3D Smart
Version Model NumberPHT-30LFO
Company DUNS689229516
Company NameVATECH CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016400014 [Primary]

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-09-16

On-Brand Devices [PaX-i3D Smart]

08800016400625Dental Computed Tomography X-ray System functioning Pano/CT/Ceph Image Acquisition (Xmaru1404CF/
08800016400618Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF/W-Pan
08800016400021Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisitio
08800016400014Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (X
08800016400007Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)

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