DIGITAL DISK RECORDER
Device Facts
| Record ID | K933115 |
|---|---|
| Device Name | DIGITAL DISK RECORDER |
| Applicant | Eigen |
| Product Code | LMB · Radiology |
| Decision Date | Apr 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2010 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.