LEKClass III
Transilluminator (diaphanoscope)
Radiology · 21 CFR 892.1990
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.
MDR events3All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Other2
Injury1
Most-reported manufacturers
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.