510(k) K242120

Device

OTOPLAN

Applicant

Cascination AG

510(k) number

K242120

Product code

QQE

Decision

Substantially Equivalent (SESE)

Decision date

2025-04-11

Date received

2024-07-19

Regulation

892.2050

Classification name

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No