The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Axiom Aristos Fx (multi Purpose Radiography System).
| Device ID | K013826 |
| 510k Number | K013826 |
| Device Name: | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) |
| Classification | System, X-ray, Stationary |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Sandra Robinson |
| Correspondent | Sandra Robinson SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-19 |
| Decision Date | 2002-02-01 |
| Summary: | summary |