FireCR Spark CG-301

GUDID 08809466040313

The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.

Digiray Corp.

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• Primary Device ID: 08809466040313
• NIH Device Record Key: 504c8b5b-b5f0-4bbd-87a4-07f1d21dc995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FireCR Spark
• Version Model Number: FR31
• Catalog Number: CG-301
• Company DUNS: 557815751
• Company Name: Digiray Corp.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr

Device Dimensions

• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter
• Weight: 21.5 Kilogram
• Width: 44.4 Centimeter
• Length: 79.5 Centimeter
• Height: 13.4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809466040313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133120

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: 6
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-10-27

On-Brand Devices [FireCR Spark]

• 08809466040511: The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and speci
• 08809466040313: The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and speci