The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for U04.
| Device ID | K010942 |
| 510k Number | K010942 |
| Device Name: | U04 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Amy Shaw Hosler |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-04-12 |