# K111292: Luminos Agile

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 3, 2011 after 28 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801623 (1980). 57 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051602: Axiom Sireskop SD, Siemens Medical Systems, Inc. (2005) Summary page 2.
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.

## Most influential descendants
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (2018), 1 descendant of its own
- K250660: LUMINOS Q.namix T; LUMINOS Q.namix R (2025), 0 descendants of its own

## Recalls of this device
- Dec 9, 2022 · Class II · Z-1001-2023: There is potential for the footrest to detach from the patient table during use.
- Apr 13, 2015 · Class II · Z-1669-2015: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image rec
- Dec 15, 2014 · Class II · Z-0994-2015: Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. l
- Sep 2, 2014 · Class II · Z-0005-2015: Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers 
- Sep 3, 2013 · Class II · Z-0374-2014: A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing lo
- Feb 15, 2012 · Not classified · Z-1159-2012: Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the imag

## Indications for use
The Luminos Agile is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

Source page: https://510kreport.com/device/K111292
Methodology: https://510kreport.com/methodology