FDA product code QXL: Cabinet, Emission Computed Tomography System
QXL is the FDA product code for cabinet, emission computed tomography system. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under QXL, 1 in the last five years. The average 510(k) review took 86 days (median 86).
Definition
Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, Emission Computed Tomography System |
| Device class | Class II |
| Regulation | 21 CFR 892.1200 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QXL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 86 |
Compare with all 510(k) review times · Search every QXL clearance
Top QXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Xeos Medical | 1 | 2023-08-10 |
Most recent QXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231420 | Xeos Medical | Aura 10 PET/CT | 2023-08-10 | 86 |
Recalls for QXL devices
openFDA lists no recalls for product code QXL.
Frequently asked questions
What is FDA product code QXL?
QXL is the FDA product code for cabinet, emission computed tomography system. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel.
What device class is QXL?
Class II, regulation 21 CFR 892.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXL?
Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most QXL clearances?
Xeos Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXL
- Run a recall and safety report across every QXL manufacturer
- Watch product code QXL 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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