QDF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Parathyroid Autofluorescence Detection Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4550
- Medical specialty
- General, Plastic Surgery
- FDA definition
- An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
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| Record | Firm | Date |
|---|---|---|
| Parathyroid Detection (Model PTeye) System (DEN170056) | Aibiomed, Corp. | 2018-11-02 |
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