X-MIND unity W0800152

GUDID D804W08001520

The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. This version includes wall plate

DE GOTZEN SRL

Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital

• Primary Device ID: D804W08001520
• NIH Device Record Key: ee370fa6-7108-4117-bf27-92e99c0cb342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-MIND unity
• Version Model Number: XMU TOP 110 SHORT CONE, INTERF WALL PLATE (16” -
• Catalog Number: W0800152
• Company DUNS: 433051802
• Company Name: DE GOTZEN SRL
• 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

Customer Support Contacts

• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D804W08001520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132378

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2018-09-03
• Device Publish Date: 2018-08-03

On-Brand Devices [X-MIND unity]

• D804W08001520: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08001510: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000910: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000850: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000230: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000170: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000160: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000150: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000140: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000130: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000120: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000110: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000100: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000090: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000080: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000070: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000060: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000050: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000040: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000030: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000020: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000010: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000000: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000930: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-
• D804W08000830: The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-