← Product Code [IXF](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXF) · K865100

# TISSUE-EQUIVALENT BREAST SIMULATOR (K865100)

_Computerized Imaging Reference Systems, Inc. · IXF · Jan 12, 1987 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXF/K865100

## Device Facts

- **Applicant:** Computerized Imaging Reference Systems, Inc.
- **Product Code:** [IXF](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXF.md)
- **Decision Date:** Jan 12, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1940
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXF/K865100](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXF/K865100)

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