QTZ
9 FDA 510(k) clearances · Product code
256 daysmedian time to decision
444 days90th percentile
9clearances measured
FDA profile
- Official device name
- Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA definition
- To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| myAblation Guide (VC10A) (K253264) | Siemens Healthcare GmbH | 2026-06-16 |
| HistoSonicsĀ® Planning Tool (K252947) | HistoSonics, Inc. | 2026-05-29 |
| BioTraceIO Vision (V1.7) (K251931) | Techsomed Medical Technologies | 2025-09-08 |
| myAblation Guide (VB80A) (K240796) | Siemens Healthcare GmbH | 2024-08-06 |
| VisAble.IO (K240773) | Techsomed | 2024-04-15 |
| Artemis, Artemis TPO, Artemis MX (K222222) | Eigen | 2023-10-12 |
| Ablation-fit (K222938) | R.A.W. S.R.L | 2023-09-12 |
| VisAble.IO (K223639) | Techsomed | 2023-08-28 |
| MIM-Ablation (K220256) | Mim Software, Inc. | 2022-10-07 |
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Every clearance here is in the API, with alerts when new ones post.