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510(k) K220727

inHEART MODELS by Inheart, Sas — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2022
Date Received
March 14, 2022
Clearance Type
Traditional
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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