FDA product code QJG: Device System, Imaging, Tympanic Membrane And Middle Ear
QJG is the FDA product code for device system, imaging, tympanic membrane and middle ear. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under QJG, 1 in the last five years. The average 510(k) review took 88 days (median 88).
Definition
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
Classification
| Field | Value |
|---|---|
| Device name | Device System, Imaging, Tympanic Membrane And Middle Ear |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QJG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 153 |
| 2022 | 1 | 24 |
Compare with all 510(k) review times · Search every QJG clearance
Top QJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Photonicare, Inc. | 2 | 2022-09-26 |
Most recent QJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222655 | Photonicare, Inc. | OtoSight Middle Ear Scope | 2022-09-26 | 24 |
| K191804 | Photonicare, Inc. | TOMi Scope | 2019-12-05 | 153 |
Recalls for QJG devices
openFDA lists no recalls for product code QJG.
Frequently asked questions
What is FDA product code QJG?
QJG is the FDA product code for device system, imaging, tympanic membrane and middle ear. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Ear, Nose and Throat panel.
What device class is QJG?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJG?
Across 2 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most QJG clearances?
Photonicare, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QJG
- Run a recall and safety report across every QJG manufacturer
- Watch product code QJG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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