DeviceClearance

Product code QQE— Radiology

OTOPLAN

Classification name
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QQE under 21 CFR 892.2050, via openFDA

Market context for product code QQE

FDA has cleared 3 devices under product code QQE between 2021 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QQE

Recent clearances under product code QQE

Data sourced from openFDA. This site is unofficial and independent of the FDA.