PaX-i Insight

GUDID 08800016400458

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

VATECH CO., LTD.

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08800016400458
NIH Device Record Key2cd4b393-e6c5-414f-842d-82fddc7d361d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaX-i Insight
Version Model NumberPCH-30CS
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016400458 [Primary]

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

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 Date2017-06-30

On-Brand Devices [PaX-i Insight]

08800016400458Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
08800016400441Dental Digital X-ray Imaging System functioning Pano Image Acquisition

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