Product code
QTZ: Radiological image processing software for ablation therapy planning and evaluation
FDA product code · Class II · Radiology
Key facts
| Product code | QTZ |
|---|---|
| Device | Radiological image processing software for ablation therapy planning and evaluation |
| Device class | Class II |
| Regulation number | 892.2050 |
| Review panel | Radiology |
| Medical specialty | Radiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database