The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Axiom Artis - Modular Angiographic System.
| Device ID | K052202 |
| 510k Number | K052202 |
| Device Name: | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-12 |
| Decision Date | 2006-03-07 |
| Summary: | summary |