FDR SE Console

GUDID 04547410414530

The FDR SE Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

FUJIFILM CORPORATION

Diagnostic x-ray digital imaging conversion system

• Primary Device ID: 04547410414530
• NIH Device Record Key: d497f3bb-09d2-4892-9ef2-1c6f227f69bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDR SE Console
• Version Model Number: DR-ID330CL
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• 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: false
• Manufacturing Date: false
• 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: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410414530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192440

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

Devices Manufactured by FUJIFILM CORPORATION

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• 14547410566335 - FUJIFILM: 2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
• 14547410566373 - FUJIFILM: 2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
• 14547410566410 - FUJIFILM: 2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
• 14547410566458 - FUJIFILM: 2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
• 14547410520580 - FUJIFILM: 2026-02-02 This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trach