DIGI-X
Device Facts
| Record ID | K834483 |
|---|---|
| Device Name | DIGI-X |
| Applicant | Radiation Measurements, Inc. |
| Product Code | LHO · Radiology |
| Decision Date | Mar 5, 1984 |
| 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.