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510(k) K251931

BioTraceIO Vision (V1.7) by Techsomed Medical Technologies — Product Code QTZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2025
Date Received: June 24, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class: Class II
Regulation Number: 892.2050
Review Panel: RA
Submission Type

To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.