510(k) K222938
K222938 is an FDA 510(k) premarket notification submitted by R.A.W. S.R.L for the device "Ablation-fit". The FDA issued a decision of Substantially Equivalent on September 12, 2023. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2023
- Date Received
- September 26, 2022
- 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.