# Medical Devices; Classification of Transilluminators (Diaphanoscopes or Lightscanners) for Breast Evaluation
> **Food and Drug Administration** · Final rule. · Published 1995-07-18 · 60 FR 36639
## Document
- **Document number:** 95-17640
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 36639
- **CFR reference:** 21 CFR 892
- **Publication date:** 1995-07-18
- **HHS docket:** Docket No. 94N-0345
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to classify the transilluminator (diaphanoscope or lightscanner) for breast evaluation into class III (premarket approval). This action is necessary to require manufacturers of transilluminators to submit a premarket approval application that includes information concerning safety and effectiveness tests for the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/07/18/95-17640/medical-devices-classification-of-transilluminators-diaphanoscopes-or-lightscanners-for-breast)
---
*AI Analytics · CC0 1.0*