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510(k) K223009

Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2022
Date Received
September 29, 2022
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

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