# K040675: Axiom Artis U

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Jun 10, 2004 after 90 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912470 (1991). 9 ancestors in all.
49 later devices descend from it; 4 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992660: Urf Digital - OT, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K010721: Axiom Artis Modular Angiography System, Siemens Medical Corp. (2001) Summary page 1.

## Most influential descendants
- K051133: Arcadis Avantic (2005), 20 descendants of its own
- K132094: Cios Alpha (2014), 19 descendants of its own
- K100371: Spy Intra-Operative Imaging System (2011), 16 descendants of its own
- K153244: Cios Fusion (2016), 15 descendants of its own
- K182907: SPY Elite Intraoperative Perfusion Assessment System (2019), 14 descendants of its own

## Recalls of this device
- Jun 29, 2011 · Not classified · Z-3009-2011: When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube ma

## Indications for use
AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis U include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g., Gastro-intestinal imaging, Skeletal imaging etc.

Source page: https://510kreport.com/device/K040675
Methodology: https://510kreport.com/methodology