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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
6 records meeting your search criteria returned- Product Code: IZL Product Problem: Thermal Decomposition of Device Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
CARESTREAM HEALTH INC. DRX REVOLUTION MOBILE X-RAY SYSTEM 12/22/2023
CARESTREAM HEALTH DRX-REVOLUTION MOBILE X-RAY SYSTEM 10/14/2021
GE MEDICAL SYSTEMS, LLC OPTIMA XR200 11/05/2020
AGFA HEALTHCARE N.V. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 06/12/2017
WSO GE MEDICAL SYSTEMS, LLC OPTIMA XR220 03/31/2017
AGFA HEALTHCARE N.V. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 07/24/2014
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