EOSedge™

GUDID 03663999000108

EOS IMAGING

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 03663999000108
• NIH Device Record Key: f0e1b9dd-0541-483c-b61f-afbdc8cc5f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EOSedge™
• Version Model Number: 4.0
• Company DUNS: 762320968
• Company Name: EOS IMAGING
• 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: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com
• Phone: 866-933-5301
• Email: contact@eos-imaging.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663999000108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192079
• Premarket Notification: K202394

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2020-03-06
• Device Publish Date: 2020-02-27

Devices Manufactured by EOS IMAGING

• 03663999000337 - VEA Align: 2024-07-15
• 03663999000313 - spineEOS: 2024-07-10
• 03663999000290 - VEA Align: 2024-06-06
• 03663999000184 - spineEOS: 2024-02-23
• 03663999000153 - sterEOS: 2024-02-22
• 03663999000061 - Radiolucent Chair: 2023-07-18
• 03663999000160 - spineEOS: 2023-07-18
• 03663999000177 - hipEOS: 2023-07-18