K882184 is an FDA 510(k) clearance for the HR-1000 W/SUFFIXES (B,C OR D). 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 June 28, 1988, 35 days after receiving the submission on May 24, 1988.
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 | K882184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1988 |
| Decision Date | June 28, 1988 |
| Days to Decision | 35 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. |