TAU Model 1000-0016 Mini C-Arm

GUDID B225100000160

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 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: B225100000160
• NIH Device Record Key: e03b79c2-26d3-468d-8734-eb68b885a7e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAU Model 1000-0016 Mini C-Arm
• Version Model Number: 1000-0016
• 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: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@orthoscan.com
• Phone: 4805038010
• Email: kevin.bridgman@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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1600 millibar

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B225100000160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183220

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

Devices Manufactured by ORTHOSCAN, INC.

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• B225100000160 - TAU Model 1000-0016 Mini C-Arm: 2021-06-04 Image-Intensified Fluoroscopic X-Ray System, Mobile
• B225100000170 - TAU Model 1000-0017 Mini C-Arm: 2021-06-04 Image-Intensified Fluoroscopic X-Ray, Mobile
• B225100000040 - OrthoScan HD Mini C-arm: 2018-07-06 Image-intensified fluoroscopic x-ray system, mobile
• B22510000004FD0 - OrthoScan Pulse Mini C-arm: 2018-07-06 Image-intensified fluoroscopic x-ray system, mobile
• B225100000050 - OrthoScan Mobile DI Mini C-arm: 2018-07-06 Image-intensified fluoroscopic x-ray system, mobile