4 devices · 4 companies · 2023 to 2026
Product code QTZ: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
4 devices under product code QTZ, 2023 to 2026, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation. 21 CFR 892.2050, Class II. To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| HistoSonics Planning ToolK252947 · 510(k) | HistoSonics, Inc. | Radiology | database entry | |
| BioTraceIO VisionK251931 · 510(k) | Techsomed Medical Technologies | Radiology | database entry | |
| VisAble.IOK240773 · 510(k) | Techsomed | Radiology | database entry | |
| VisAble.IOK223639 · 510(k) | TechsoMed | Radiology | database entry |
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