510(k) DEN230020
DEN230020 is an FDA 510(k) premarket notification submitted by Techsomed Medical Technologies , Ltd. for the device "BioTraceIO Lite". The FDA issued a decision of De Novo Granted on December 22, 2023. The device falls under product code QZL (Post-Ablation Tissue Response Prediction Software), a Class II device regulated under 21 CFR 892.2052. Techsomed Medical Technologies , Ltd. has at least 2 other 510(k) clearances on record.
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.