510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LEKClass III

Transilluminator (Diaphanoscope)

21 CFR 892.1990 / Radiology
FDA source (opens on fda.gov)

LEK is the FDA product code for Transilluminator (Diaphanoscope), a class III device type, regulated under 21 CFR 892.1990. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
LEK
Device name
Transilluminator (Diaphanoscope)
FDA 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.
Regulation
21 CFR 892.1990
Device class
Class III
Review panel
Radiology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LEK.