QQE — Image Management Software For Planning Of Otologic And Neurotologic Procedures Class II

FDA Device Classification

Classification Details

Product Code
QQE
Device Class
Class II
Regulation Number
892.2050
Submission Type
Review Panel
EN
Medical Specialty
Radiology
Implant
No

Definition

Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242120cascinationOTOPLANApril 11, 2025
K220300cascinationOTOPLANJune 24, 2022
K203486cascinationOtoplanAugust 20, 2021