K901956 is an FDA 510(k) clearance for the DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.). 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 July 2, 1990, 62 days after receiving the submission on May 1, 1990.
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 | K901956 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1990 |
| Decision Date | July 02, 1990 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| 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. |