The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Modular Angiography System Axiom Artis.
Device ID | K021021 |
510k Number | K021021 |
Device Name: | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Sandra Robinson |
Correspondent | Sandra Robinson SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-29 |
Decision Date | 2002-06-06 |
Summary: | summary |