The following data is part of a premarket notification filed by Medison Radiology Systems, Inc. with the FDA for Mca-601, C-arm Mobile.
| Device ID | K993896 |
| 510k Number | K993896 |
| Device Name: | MCA-601, C-ARM MOBILE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | MEDISON RADIOLOGY SYSTEMS, INC. 2000 LEHIGH AVE. Glenview, IL 60025 |
| Contact | John W Lee |
| Correspondent | John W Lee MEDISON RADIOLOGY SYSTEMS, INC. 2000 LEHIGH AVE. Glenview, IL 60025 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-03-27 |
| Summary: | summary |