QJG · Class II · 21 CFR 892.1560

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
1–2 of 2
Cleared Sep 26, 2022
OtoSight Middle Ear Scope
K222655
Photonicare, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 05, 2019
TOMi Scope
K191804
Photonicare, Inc.
Ear, Nose, Throat · 153d

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.