Product code LEK
- Device name
- Transilluminator (Diaphanoscope)
- Medical specialty
- Radiology
- Device class
- 3
- Regulation number
- 892.1990
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset