Home / 510(k) Clearances / K252934

510(k) K252934

Diagnocat by DGNCT, LLC — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
September 15, 2025
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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