# Transilluminator (Diaphanoscope)
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=LEK)
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