# K203486: Otoplan

- Pathway: 510(k) (Traditional)
- Applicant: Cascination AG
- Decided: Aug 20, 2021 after 266 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: 9 generations back to K924630 (1993). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201465: SuRgical Planner (SRP) BrainStorm, Surgical Theater, Inc. (2020) Summary page 4.

## Most influential descendants
- K242120: Otoplan (2025), 0 descendants of its own
- K220300: Otoplan (2022), 0 descendants of its own

## 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/K203486
Methodology: https://510kreport.com/methodology