← Product Code [IYH](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYH) · K871116

# X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R (K871116)

_X-Cel X-Ray Corp. · IYH · May 14, 1987 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYH/K871116

## Device Facts

- **Applicant:** X-Cel X-Ray Corp.
- **Product Code:** [IYH](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYH.md)
- **Decision Date:** May 14, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5900
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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/IYH/K871116](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYH/K871116)

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