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LEK — Transilluminator (Diaphanoscope) Class III

FDA Device Classification

Classification Details

Product Code
LEK
Device Class
Class III
Regulation Number
892.1990
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

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.