OrthoScan HD Mini C-arm

GUDID B225100000040

Image-intensified fluoroscopic x-ray system, mobile

ORTHOSCAN, INC.

Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: B225100000040
• NIH Device Record Key: 5c96a1d0-d4c0-4e89-aa01-b6b84ed67bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoScan HD Mini C-arm
• Version Model Number: 1000-0004
• Company DUNS: 196554021
• Company Name: ORTHOSCAN, INC.
• 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: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com
• Phone: 480-503-8010
• Email: steve.seeman@orthoscan.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B225100000040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051754

FDA Product Code

• OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

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: 2017-03-07

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