FDA Product Code QJG: Device System, Imaging, Tympanic Membrane And Middle Ear
Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space.
Leading manufacturers include Photonicare, Inc..
2
Total
2
Cleared
89d
Avg days
2019
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Device System, Imaging, Tympanic Membrane And Middle Ear Devices (Product Code QJG)
2 devices
About Product Code QJG - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QJG since 2019, with 2 receiving FDA clearance (average review time: 89 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QJG devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →