510(k) K262080
K262080 is an FDA 510(k) premarket notification submitted by Cascination AG for the device "OTOPLAN". The FDA issued a decision of Substantially Equivalent on Oct 23, 2026. The device falls under product code QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures), a Class II device regulated under 21 CFR 892.2050. Cascination AG has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2026
- Date Received
- Jun 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image Management Software For Planning Of Otologic And Neurotologic Procedures
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- EN
- Submission Type
- 510(k)
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.