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510(k) K183541

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems by Prognosys Medical Systems Private Limited — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2019
Date Received
December 20, 2018
Clearance Type
Traditional
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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