510(k) clearance
OTOPLAN
- 510(k) number
- K262080
- Applicant
- Cascination AG
- Decision date
- Oct 23, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QQE
- Device type
- Image Management Software For Planning Of Otologic And Neurotologic Procedures
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Bern, CH