X-MIND trium W0900004

GUDID D804W09000040

X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right

DE GOTZEN SRL

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• Primary Device ID: D804W09000040
• NIH Device Record Key: e04d79a6-c305-43a1-a367-76c13cbbb960
• Commercial Distribution Discontinuation: 2016-12-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: X-MIND trium
• Version Model Number: XMT PAN 3D R
• Catalog Number: W0900004
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D804W09000040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160166

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-15

On-Brand Devices [X-MIND trium]

• D804W09002400: X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the rig
• D804W09002390: X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the lef
• D804W09002330: X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel o
• D804W09002320: X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the le
• D804W09002310: X-MIND trium PAN CBCT CEPH version including one PAN sensor,with control panel on the right sid
• D804W09002300: X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the ri
• D804W09002260: X-MIND trium PAN T version including one removable pan sensor with control panel on the left co
• D804W09002250: X-MIND trium PAN T version including one removable pan sensor with control panel on the right c
• D804W09000560: X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the left side inclu
• D804W09000550: X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the right side incl
• D804W09000120: X-MIND trium PAN CBCT including one removable pan sensor and a CBCT sensor, with control panel o
• D804W09000110: X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the left side incl
• D804W09000100: X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control
• D804W09000090: X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the le
• D804W09000080: X-MIND trium PAN version including one PAN sensor, with control panel on the left side including
• D804W09000070: X-MIND trium PAN version including one PAN sensor, with control panel on the left side
• D804W09000060: X-MIND trium PAN CBCT CEPH version including one PAN sensor, with control panel on the right si
• D804W09000050: X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the right side in
• D804W09000040: X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control
• D804W09000030: X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the ri
• D804W09000020: X-MIND trium PAN version including one PAN sensor, with control panel on the right side includin
• D804W09000010: X-MIND trium PAN version including one PAN sensor,with control panel on the right side