# K061054: Axiom Aristos FX Plus

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 9, 2006 after 22 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801623 (1980). 41 ancestors in all.
80 later devices descend from it; 4 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013826: Axiom Aristos FX (Multi Purpose Radiography System), Siemens Medical Systems, Inc. (2002) Summary page 2.
- K052202: Axiom Artis - Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2006) Summary page 2.

## Most influential descendants
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K081722: YSIO (2008), 43 descendants of its own
- K121513: Multix Fusion (2012), 32 descendants of its own
- K133259: Ysio Max (2014), 23 descendants of its own
- K142049: Multix Fusion VA30 & VA40 (2014), 18 descendants of its own

## Recalls of this device
- Apr 6, 2020 · Class II · Z-1765-2020: It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less 
- Dec 12, 2011 · Not classified · Z-0860-2012: Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.
- Feb 17, 2011 · Not classified · Z-1959-2011: During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216

## Indications for use
AXIOM Aristos FX Plus is a dedicated x-ray system with a flat panel detector, which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The AXIOM Aristos FX Plus allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

Source page: https://510kreport.com/device/K061054
Methodology: https://510kreport.com/methodology