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510(k) K243084

BioTraceIO Precision (2.0) by Techsomed Medical Technologies , Ltd. — Product Code QZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2024
Date Received
September 30, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post-Ablation Tissue Response Prediction Software
Device Class
Class II
Regulation Number
892.2052
Review Panel
RA
Submission Type

A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.

Other clearances by Techsomed Medical Technologies , Ltd.

  • K251931 — BioTraceIO Vision (V1.7) (September 8, 2025)
  • DEN230020 — BioTraceIO Lite (December 22, 2023)

Other clearances for product code QZL

  • DEN230020 — BioTraceIO Lite (December 22, 2023)