510(k) DEN170056
DEN170056 is an FDA 510(k) premarket notification submitted by Aibiomed, Corp. for the device "Parathyroid Detection (Model PTeye) System". The FDA issued a decision of De Novo Granted on November 2, 2018. The device falls under product code QDF (Parathyroid Autofluorescence Detection Device), a Class II device regulated under 21 CFR 878.4550.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 2, 2018
- Date Received
- September 25, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parathyroid Autofluorescence Detection Device
- Device Class
- Class II
- Regulation Number
- 878.4550
- Review Panel
- SU
- Submission Type
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.