# DEN170056: Parathyroid Detection (Model PTeye) System

- Pathway: De Novo (Direct)
- Applicant: Aibiomed, Corp.
- Decided: Nov 2, 2018 after 403 days
- Product code: QDF (Parathyroid Autofluorescence Detection Device)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The AiBiomed Parathyroid Detection System (Model PTeye) is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.

Source page: https://510kreport.com/device/DEN170056
Methodology: https://510kreport.com/methodology