The following data is part of a premarket notification filed by United Radiology Systems, Inc. with the FDA for Kmc-950 C-arm Mobile System.
| Device ID | K032761 |
| 510k Number | K032761 |
| Device Name: | KMC-950 C-ARM MOBILE SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | UNITED RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. UNIT T Deerfield, IL 60015 |
| Contact | John W Lee |
| Correspondent | John W Lee UNITED RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. UNIT T Deerfield, IL 60015 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-05 |
| Decision Date | 2004-05-14 |
| Summary: | summary |