K220300 is an FDA 510(k) clearance for the OTOPLAN. This device is classified as a Image Management Software For Planning Of Otologic And Neurotologic Procedures (Class II - Special Controls, product code QQE).
Submitted by Cascination AG (Bern, CH). The FDA issued a Cleared decision on June 24, 2022, 142 days after receiving the submission on February 2, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 892.2050. Display, Segmentation, And Transfer Of Medical Image Data From Medical Imaging Systems For Planning Of Otological And Neurotological Procedures..
| 510(k) Number | K220300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2022 |
| Decision Date | June 24, 2022 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QQE - Image Management Software For Planning Of Otologic And Neurotologic Procedures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | Display, Segmentation, And Transfer Of Medical Image Data From Medical Imaging Systems For Planning Of Otological And Neurotological Procedures. |