The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Image Management System (mims).
| Device ID | K883604 |
| 510k Number | K883604 |
| Device Name: | MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Contact | Ruey C Dempsey |
| Correspondent | Ruey C Dempsey MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-24 |
| Decision Date | 1988-11-15 |