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510(k) K242120

OTOPLAN by Cascination AG — Product Code QQE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 11, 2025
Date Received: July 19, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Image Management Software For Planning Of Otologic And Neurotologic Procedures
Device Class: Class II
Regulation Number: 892.2050
Review Panel: EN
Submission Type

Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.