TISSUE-EQUIVALENT BREAST SIMULATOR
Device Facts
| Record ID | K865100 |
|---|---|
| Device Name | TISSUE-EQUIVALENT BREAST SIMULATOR |
| Applicant | Computerized Imaging Reference Systems, Inc. |
| Product Code | IXF · Radiology |
| Decision Date | Jan 12, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1940 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
