# K013826: Axiom Aristos FX (Multi Purpose Radiography System)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Feb 1, 2002 after 74 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K803130 (1981). 6 ancestors in all.
81 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983732: Thorax FD and Multix FD, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K951176: Koordinat M, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own
- 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

## Recalls of this device
- Apr 6, 2020 · Class II · Z-1764-2020: 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 
- Apr 14, 2015 · Class II · Z-1583-2015: If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
- 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
- Aug 25, 2008 · Not classified · Z-0163-2009: Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
- Jun 10, 2005 · Not classified · Z-0989-05: potential issue (system may lock up) when repeating patient registrations
- Jun 10, 2005 · Not classified · Z-0990-05: potential issue (system may lock up) when repeating patient registrations
- Jun 10, 2005 · Not classified · Z-0988-05: potential issue (system may lock up) when repeating patient registrations
- Apr 19, 2003 · Not classified · Z-0984-03: software malfunction. May indicate that the image is flipped when it is not.

## Indications for use
MPRS 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 MPRS 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 supine 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/K013826
Methodology: https://510kreport.com/methodology