FDA product code QQE: Image Management Software For Planning Of Otologic And Neurotologic Procedures
QQE is the FDA product code for image management software for planning of otologic and neurotologic procedures. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under QQE, 2 in the last five years. The average 510(k) review took 225 days (median 266); 266 days on average over the last three years.
Definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
Classification
| Field | Value |
|---|---|
| Device name | Image Management Software For Planning Of Otologic And Neurotologic Procedures |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QQE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 266 |
| 2022 | 1 | 142 |
| 2025 | 1 | 266 |
Compare with all 510(k) review times · Search every QQE clearance
Top QQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cascination AG | 3 | 2025-04-11 |
Most recent QQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242120 | Cascination AG | OTOPLAN | 2025-04-11 | 266 |
| K220300 | Cascination AG | OTOPLAN | 2022-06-24 | 142 |
| K203486 | Cascination AG | Otoplan | 2021-08-20 | 266 |
Recalls for QQE devices
openFDA lists no recalls for product code QQE.
Frequently asked questions
What is FDA product code QQE?
QQE is the FDA product code for image management software for planning of otologic and neurotologic procedures. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Ear, Nose and Throat panel.
What device class is QQE?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQE?
Across 3 cleared submissions the average was 225 days from receipt to decision (median 266).
Which companies have the most QQE clearances?
Cascination AG (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QQE
- Run a recall and safety report across every QQE manufacturer
- Watch product code QQE 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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