FireCR Flash CG-401

GUDID 08809466040412

The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution.

Digiray Corp.

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• Primary Device ID: 08809466040412
• NIH Device Record Key: 7e5e5839-f84a-4fb7-b0ec-cda36e7774f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FireCR Flash
• Version Model Number: FR41
• Catalog Number: CG-401
• 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	08809466040412 [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: 7
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-06-30

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