Product code QDF
- Product
- Parathyroid Autofluorescence Detection Device
- 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.
- Description
- General & Plastic Surgery General Optical Products / Medical
- Regulation number
- 878.4550
- Radiation type
- Optical
- Applicable standards
- None
Current FDA Classification
- Device name
- Parathyroid Autofluorescence Detection Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4550
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN170056 | Parathyroid Detection (Model PTeye) System | Aibiomed, Corp. | 2018-11-02 |