QTZ
- Product code
- QTZ
- Device name
- Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
FDA classification definition
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253264 | 2026-06-16 | Siemens Healthcare GmbH | myAblation Guide (VC10A) | FDA |
| K252947 | 2026-05-29 | HistoSonics, Inc. | HistoSonics® Planning Tool | |
| K251931 | 2025-09-08 | Techsomed Medical Technologies | BioTraceIO Vision (V1.7) | |
| K240796 | 2024-08-06 | Siemens Healthcare GmbH | myAblation Guide (VB80A) | |
| K240773 | 2024-04-15 | Techsomed | VisAble.IO | |
| K222222 | 2023-10-12 | Eigen | Artemis, Artemis TPO, Artemis MX | |
| K222938 | 2023-09-12 | R.A.W. S.R.L | Ablation-fit |
Official FDA classification page: QTZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).