NewTom P70720008

GUDID 08033837931379

X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.

CEFLA SOCIETA' COOPERATIVA

Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system

• Primary Device ID: 08033837931379
• NIH Device Record Key: cc662afa-7733-4ee3-bb96-e26fff5d8a71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewTom
• Version Model Number: NewTom 5G XL
• Catalog Number: P70720008
• Company DUNS: 437681152
• Company Name: CEFLA SOCIETA' COOPERATIVA
• 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: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837931379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183448

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2019-04-09
• Device Publish Date: 2019-04-01