Product code LEK

Device name

Transilluminator (Diaphanoscope)

Medical specialty

Radiology

Device class

3

Regulation number

892.1990

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset