The following data is part of a premarket notification filed by Medical Knowledge Systems, Inc. with the FDA for Ram-pacs.
| Device ID | K933493 |
| 510k Number | K933493 |
| Device Name: | RAM-PACS |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL KNOWLEDGE SYSTEMS, INC. 3800 WOODWARD AVE. SUITE 900 Detroit, MI 48201 |
| Contact | Scott Taylor |
| Correspondent | Scott Taylor MEDICAL KNOWLEDGE SYSTEMS, INC. 3800 WOODWARD AVE. SUITE 900 Detroit, MI 48201 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1993-11-03 |