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510(k) K243473

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS by Prognosys Medical Systems Private Limited — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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