Transilluminator (Diaphanoscope)

LEK · Class III — High Risk (PMA approval required, life-sustaining) · Radiology · 21 CFR 892.1990

Classification

FDA Product Code: LEK
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 892.1990
Review panel: RA
Medical specialty: Radiology
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown