DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
Device Facts
| Record ID | K901956 |
|---|---|
| Device Name | DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) |
| Applicant | Eigen |
| Product Code | LMB · Radiology |
| Decision Date | Jul 2, 1990 |
| 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.