PaX-i3D Green Premium / Green 21

GUDID 08800016400359

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)

VATECH CO., LTD.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800016400359
• NIH Device Record Key: 54f4ca17-faa9-43bf-add3-8d7371261008
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PaX-i3D Green Premium / Green 21
• Version Model Number: PCT-90LH
• Company DUNS: 689229516
• Company Name: VATECH CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800016400359 [Primary]

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2017-06-30

Devices Manufactured by VATECH CO., LTD.

• 08800016401950 - VistaPano S 2.0: 2024-12-23 Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF-PLUS)
• 08800016401967 - VistaPano S Ceph 2.0: 2024-12-23 Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
• 08800016400069 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 9
• 08800016400076 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(V))
• 08800016400083 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V) / Xm
• 08800016400090 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V)
• 08800016400106 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V)
• 08800016400137 - PaX-i3D Green: 2024-03-18 Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(H)