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510(k) K242437

Smile Dx® by Cube Click, Inc. — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2025
Date Received
August 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Medical Image
Device Class
Class II
Regulation Number
892.2070
Review Panel
RA
Submission Type

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

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