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510(k) DEN230020

BioTraceIO Lite by Techsomed Medical Technologies , Ltd. — Product Code QZL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 22, 2023
Date Received
March 30, 2023
Clearance Type
Direct
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)
  • K243084 — BioTraceIO Precision (2.0) (December 27, 2024)

Other clearances for product code QZL

  • K243084 — BioTraceIO Precision (2.0) (December 27, 2024)