510(k) K251931
K251931 is an FDA 510(k) premarket notification submitted by Techsomed Medical Technologies for the device "BioTraceIO Vision (V1.7)". The FDA issued a decision of Substantially Equivalent on September 8, 2025. The device falls under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation), a Class II device regulated under 21 CFR 892.2050. Techsomed Medical Technologies has at least 2 other 510(k) clearances on record.
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.