Aquarius 8600

GUDID 00823073005211

Flat Panel Digital Medical X-Ray Detector.

Imaging Dynamics Company Ltd

Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system

• Primary Device ID: 00823073005211
• NIH Device Record Key: fcf97c17-1fbc-4006-8de0-e43b287d6c66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquarius 8600
• Version Model Number: 1417WCI
• Company DUNS: 252909973
• Company Name: Imaging Dynamics Company Ltd
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 403-251-9939
• Email: info@imagingdynamics.com
• Phone: 403-251-9939
• Email: info@imagingdynamics.com

Device Dimensions

• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00823073005211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173273

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-11-28

On-Brand Devices [Aquarius 8600]

• 00823073005211: Flat Panel Digital Medical X-Ray Detector.
• 00823073005112: Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
• 00823073003217: Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
• 00823073002111: Flat Panel Digital Medical X-Ray Imaging Detector.