Parathyroid Autofluorescence Detection Device
The Parathyroid Autofluorescence Detection Device is an adjunct surgical tool that uses autofluorescence to detect and locate parathyroid tissues or structures during general surgery; it is not intended to provide a diagnosis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDF under regulation 878.4550 in the General and Plastic Surgery specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDF
- Device Class
- FDA class 2
- Regulation Number
- 878.4550
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170056 | Parathyroid Detection (Model PTeye) System | Nov 02, 2018 | Unknown | Aibiomed, Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.