K960941 is an FDA 510(k) clearance for the UPACS. This device is classified as a Device, Digital Image Storage, Radiological (Class I - General Controls, product code LMB).
Submitted by Base Ten Systems, Inc. (Trenton, US). The FDA issued a Cleared decision on June 3, 1996, 87 days after receiving the submission on March 8, 1996.
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 | K960941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1996 |
| Decision Date | June 03, 1996 |
| Days to Decision | 87 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. |