DR-ID900CL

GUDID 04547410316872

The DR-ID 900CL is a workstation intended to associate digital (for CR and/or 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

Computed radiography digital imaging scanner
Primary Device ID04547410316872
NIH Device Record Key18288273-50f1-432b-9ab8-629712ab56b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR-ID900CL
Version Model NumberDR-ID900CL
Company DUNS713565195
Company NameFUJIFILM CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410316872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-09-16

Devices Manufactured by FUJIFILM CORPORATION

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04547410515893 - FUJIFILM2024-10-14 This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to
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14547410528265 - FUJIFILM2024-09-30 FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the

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