QQE

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Product code
QQE
Device name
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Device class
Class 2
21 CFR
21 CFR 892.2050
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-11.

NumberDecision dateApplicantDevice nameSummary
K2421202025-04-11Cascination AGOTOPLANPDF

1 summaries are archived here for direct download.

Official FDA classification page: QQE
Classification and pathway per current FDA publications. Data from openFDA (CC0).