Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1990](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1990) → LEK — Transilluminator (Diaphanoscope)

# LEK · Transilluminator (Diaphanoscope)

_Radiology · 21 CFR 892.1990 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LEK

## Overview

- **Product Code:** LEK
- **Device Name:** Transilluminator (Diaphanoscope)
- **Regulation:** [21 CFR 892.1990](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1990)
- **Device Class:** 3
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LEK](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LEK)

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