The following data is part of a premarket notification filed by Medical Image Processing Specialists, Inc. with the FDA for Report And Image Management System.
| Device ID | K882754 |
| 510k Number | K882754 |
| Device Name: | REPORT AND IMAGE MANAGEMENT SYSTEM |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | MEDICAL IMAGE PROCESSING SPECIALISTS, INC. 6087 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Patrick F Leonard |
| Correspondent | Patrick F Leonard MEDICAL IMAGE PROCESSING SPECIALISTS, INC. 6087 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-05 |
| Decision Date | 1988-10-21 |