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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K210469
Device Name Insight Agile DRF
Applicant
Imaging Engineering, LLC
1318 NW 7th Ave.
Cape Coral,  FL  33993
Applicant Contact George Jachode
Correspondent
Imaging Engineering, LLC
1318 NW 7th Ave.
Cape Coral,  FL  33993
Correspondent Contact George Jachode
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
OWB   OXO   QHY   RCC  
Date Received02/16/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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