QJG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Medical specialty
- Radiology
- FDA definition
- Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
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| Record | Firm | Date |
|---|---|---|
| OtoSight Middle Ear Scope (K222655) | Photonicare, Inc. | 2022-09-26 |
| TOMi Scope (K191804) | Photonicare, Inc. | 2019-12-05 |
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Every clearance here is in the API, with alerts when new ones post.