510(k) Premarket Notification Database
| Device Classification Name |
SYSTEM, DIGITAL IMAGE COMMUNICATIONS,
RADIOLOGICAL |
| Regulation Number |
892.2020 |
| 510(k) Number |
K943994 |
| Device Name |
PACS EQUIPMENT |
| Applicant |
| RSTAR IMAGE MANAGEMENT SYSTEM |
| ONE CAMBRIDGE CENTER |
| CAMBRIDGE, MA 02142
| |
| Contact |
MORTEZA MINAEE |
| Product Code |
LMD |
| Date Received |
08/16/1994 |
| Decision Date |
05/12/1995 |
| Decision |
SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory Committee |
Radiology |
| Review Advisory Committee |
Radiology |
| Statement/Summary/Purged Status |
Statement only |
| Type |
Traditional
|
| Reviewed by Third Party |
No |
| Expedited Review |
No
| | |
