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510(k) K242062

1CMR Pro by Mycardium AI Limited — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2024
Date Received
July 15, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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