The following data is part of a premarket notification filed by Siemens Medical Corp. with the FDA for Axiom Artis Modular Angiography System.
| Device ID | K010721 |
| 510k Number | K010721 |
| Device Name: | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Praveen Nadkarni |
| Correspondent | Praveen Nadkarni SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-03-30 |