← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K905007

# STANDARD BREAST BOARDS;  DELUXE BREAST BOARD (K905007)

_Bionix Development Corp. · IYE · Feb 12, 1991 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K905007

## Device Facts

- **Applicant:** Bionix Development Corp.
- **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md)
- **Decision Date:** Feb 12, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K905007](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K905007)

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