Green X

GUDID 08800016400717

Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X (Model: PHT-75CHS)is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.

VATECH CO., LTD.

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• Primary Device ID: 08800016400717
• NIH Device Record Key: e631d012-4130-4eb1-8995-1ed19847ef4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Green X
• Version Model Number: PHT-75CHS
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800016400717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201627

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-03
• Device Publish Date: 2022-07-26

On-Brand Devices [Green X ]

• 08800016400717: Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-
• 08800016400700: Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-