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510(k) K210469

Insight Agile DRF by Imaging Engineering, LLC — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2021
Date Received
February 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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