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510(k) K191310

Insight Essentials DRF Digital Imaging System by Imaging Engineering, LLC — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2019
Date Received
May 15, 2019
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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