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510(k) K231709

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 by Radmedix, LLC — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2023
Date Received
June 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Radmedix, LLC

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