FDA product code QTZ: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QTZ is the FDA product code for radiological image processing software for ablation therapy planning and evaluation. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 9 510(k) submissions under QTZ, 9 in the last five years, from 7 different applicants. The average 510(k) review took 229 days (median 256); 138 days on average over the last three years.
Definition
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Classification
| Field | Value |
|---|---|
| Device name | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QTZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 249 |
| 2023 | 3 | 354 |
| 2024 | 2 | 81 |
| 2025 | 1 | 76 |
| 2026 | 2 | 258 |
Compare with all 510(k) review times · Search every QTZ clearance
Top QTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Healthcare GmbH | 2 | 2026-06-16 |
| Techsomed | 2 | 2024-04-15 |
| HistoSonics, Inc. | 1 | 2026-05-29 |
| Techsomed Medical Technologies | 1 | 2025-09-08 |
| Eigen | 1 | 2023-10-12 |
2 more applicants have QTZ clearances. See the full list in Caduvo.
Most recent QTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253264 | Siemens Healthcare GmbH | myAblation Guide (VC10A) | 2026-06-16 | 260 |
| K252947 | HistoSonics, Inc. | HistoSonics® Planning Tool | 2026-05-29 | 256 |
| K251931 | Techsomed Medical Technologies | BioTraceIO Vision (V1.7) | 2025-09-08 | 76 |
| K240796 | Siemens Healthcare GmbH | myAblation Guide (VB80A) | 2024-08-06 | 137 |
| K240773 | Techsomed | VisAble.IO | 2024-04-15 | 25 |
Recalls for QTZ devices
openFDA lists no recalls for product code QTZ.
Frequently asked questions
What is FDA product code QTZ?
QTZ is the FDA product code for radiological image processing software for ablation therapy planning and evaluation. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is QTZ?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTZ?
Across 9 cleared submissions the average was 229 days from receipt to decision (median 256).
Which companies have the most QTZ clearances?
Siemens Healthcare GmbH (2); Techsomed (2); HistoSonics, Inc. (1); Techsomed Medical Technologies (1); Eigen (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTZ
- Run a recall and safety report across every QTZ manufacturer
- Watch product code QTZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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