The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Axiom Artis U.
| Device ID | K040675 |
| 510k Number | K040675 |
| Device Name: | AXIOM ARTIS U |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Debra Peacock |
| Correspondent | Debra Peacock SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| 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 | 2004-03-12 |
| Decision Date | 2004-06-10 |
| Summary: | summary |