510(k) K220300
K220300 is an FDA 510(k) premarket notification submitted by Cascination AG for the device "OTOPLAN". The FDA issued a decision of Substantially Equivalent on June 24, 2022. 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 at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2022
- Date Received
- February 2, 2022
- 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
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.