LEK

Transilluminator (Diaphanoscope)

Product code: LEK
Device name: Transilluminator (Diaphanoscope)
Device class: Class 3
21 CFR: 21 CFR 892.1990
Medical specialty: Radiology
Marketing pathway: PMA

FDA classification definition

Classified August 17, 1995: 60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: LEK

Classification and pathway per current FDA publications. Data from openFDA (CC0).