QQE
- Product code
- QQE
- Device name
- Image Management Software For Planning Of Otologic And Neurotologic Procedures
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242120 | 2025-04-11 | Cascination AG | OTOPLAN |
Official FDA classification page: QQE
Classification and pathway per current FDA publications. Data from openFDA (CC0).