X-CEL X-RAY CORPORATION

GUDID B216P700MAC1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV

ARQUILLA, INC.

Stationary basic diagnostic x-ray system, analogue

• Primary Device ID: B216P700MAC1
• NIH Device Record Key: cd62ca42-cc87-4f95-9db0-08599434d492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CEL X-RAY CORPORATION
• Version Model Number: P700M A/C
• Company DUNS: 062469945
• Company Name: ARQUILLA, 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: true
• 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: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com
• Phone: 8154552470
• Email: guido@xcelxray.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B216P700MAC1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811230

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: 2022-08-15
• Device Publish Date: 2022-08-05

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