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510(k) K223060

DigiX FDX by Allengers Medical Systems Limited — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2022
Date Received
September 30, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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