K933115 is an FDA 510(k) clearance for the DIGITAL DISK RECORDER. This device is classified as a Device, Digital Image Storage, Radiological (Class I - General Controls, product code LMB).
Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on April 7, 1994, 286 days after receiving the submission on June 25, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2010. Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images..
| 510(k) Number | K933115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1993 |
| Decision Date | April 07, 1994 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMB - Device, Digital Image Storage, Radiological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.2010 |
| Definition | Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images. |