QQE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Image Management Software For Planning Of Otologic And Neurotologic Procedures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA definition
- Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
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| Record | Firm | Date |
|---|---|---|
| OTOPLAN (K242120) | Cascination AG | 2025-04-11 |
| OTOPLAN (K220300) | Cascination AG | 2022-06-24 |
| Otoplan (K203486) | Cascination AG | 2021-08-20 |
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