DeviceClearance

Product code QJG— Radiology

OtoSight Middle Ear Scope

Classification name
Device System, Imaging, Tympanic Membrane And Middle Ear
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.”

— U.S. Food and Drug Administration, device classification record for product code QJG under 21 CFR 892.1560, via openFDA

Market context for product code QJG

FDA has cleared 2 devices under product code QJG between 2019 and 2022, 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 QJG

Recent clearances under product code QJG

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