FDA.reportPublic FDA data

Intraoperative parathyroid detection system control unit

Definition
An electrically-powered component of an intraoperative parathyroid detection system designed to aid surgeons in recognizing parathyroid tissue during open surgical thyroidectomies and parathyroidectomies using near-infrared (NIR) light and auto-fluorescence. It consists of a console with display and controls. The NIR light is emitted, and the florescence measured, using a single-use invasive probe (not included).
GUDID devices
6
Last updated
2024-05-14 08:10:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B475FBLXR0FLUOBEAM LX RedFLUOPTICSFBLXR2024-05-06
00763000849573PTEYE Parathyroid Detection SystemMEDTRONIC XOMED, INC.PTEYE2024-04-04
00763000849580PTEYE Parathyroid Detection SystemMEDTRONIC XOMED, INC.PTEYE-RF2024-04-04
00763000497163PTEYEMEDTRONIC XOMED, INC.PTEYE-RF2023-11-27
00763000497040PTEYEMEDTRONIC XOMED, INC.PTEYE2023-09-16
00865124000431PTeye Parathyroid Detection SystemAiBiomedPTeye2019-12-10