Xplorer 1600 Plus Digital Radiographic System

GUDID 00823073051010

Digital Radiographic System

Imaging Dynamics Company Ltd

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00823073051010
• NIH Device Record Key: 9e8fb3cd-e19d-42cd-a7d2-034b47c64d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xplorer 1600 Plus Digital Radiographic System
• Version Model Number: 1600 X4C
• 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: +1(403)251-9939
• Email: info@imagingdynamics.com
• Phone: +1(403)251-9939
• Email: info@imagingdynamics.com

Device Dimensions

• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter
• Height: 2645 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00823073051010 [Primary]

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: 2018-03-29
• Device Publish Date: 2017-01-26

Devices Manufactured by Imaging Dynamics Company Ltd

• 00823073004016 - Flat Panel Fixed/Portable System: 2019-05-07 Flat Panel Detector
• 00823073002111 - Aquarius 8600: 2019-02-21 Flat Panel Digital Medical X-Ray Imaging Detector.
• 00823073003217 - Aquarius 8600: 2019-02-21 Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
• 00823073005112 - Aquarius 8600: 2019-02-21 Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
• 00823073005211 - Aquarius 8600: 2019-02-21 Flat Panel Digital Medical X-Ray Detector.
• 00823073001015 - Xplorer 1000 Detector Head (X4C): 2018-03-29 CCD Detector
• 00823073001022 - X3C Detector Head: 2018-03-29 CCD Detector
• 00823073001039 - Xaminer Detector Head: 2018-03-29 CCD Detector