QDF — Parathyroid Autofluorescence Detection Device Class II
FDA product code QDF covers "Parathyroid Autofluorescence Detection Device", a Class II medical device regulated under 21 CFR 878.4550. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QDF
- Device Class
- Class II
- Regulation Number
- 878.4550
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170056 | aibiomed | Parathyroid Detection (Model PTeye) System | November 2, 2018 |