# K220300: Otoplan

- Pathway: 510(k) (Traditional)
- Applicant: Cascination AG
- Decided: Jun 24, 2022 after 142 days
- Product code: QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K924630 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203486: Otoplan, Cascination AG (2021) Summary page 5.

## Indications for use
OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).

Source page: https://510kreport.com/device/K220300
Methodology: https://510kreport.com/methodology