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510(k) K234141

AISAP Cardio V1.0 by Aisap — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
December 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class
Class II
Regulation Number
892.2060
Review Panel
RA
Submission Type

Assist users in characterizing lesions identified on acquired medical images

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