510(k) K240773
K240773 is an FDA 510(k) premarket notification submitted by Techsomed for the device "VisAble.IO". The FDA issued a decision of Substantially Equivalent on April 15, 2024. 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 has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2024
- Date Received
- March 21, 2024
- Clearance Type
- Special
- 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.