Green 16

GUDID 08800016400595

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1314CF/G2/MASTER)

VATECH CO., LTD.

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• Primary Device ID: 08800016400595
• NIH Device Record Key: 43b93a68-84bd-4405-863f-1353536ce50a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Green 16
• Version Model Number: PHT-65LHS
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	08800016400595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170066

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: 2
• Public Version Date: 2021-06-22
• Device Publish Date: 2018-08-13

On-Brand Devices [Green 16]

• 08800016400601: Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (X
• 08800016400595: Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1314CF/G2/MA
• 08800016400397: Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
• 08800016400380: Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition