DeviceClearance

Product code QDF— General, Plastic Surgery

Parathyroid Detection (Model PTeye) System

Classification name
Parathyroid Autofluorescence Detection Device
Device class
Class 2
Regulation
21 CFR 878.4550
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QDF under 21 CFR 878.4550, via openFDA

Market context for product code QDF

FDA has cleared 1 device under product code QDF, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QDF

Recent clearances under product code QDF

Data sourced from openFDA. This site is unofficial and independent of the FDA.