# K062623: Axiom Luminos DRF

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 22, 2007 after 351 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K801623 (1980). 55 ancestors in all.
78 later devices descend from it; 10 cite it directly.
0 of 134 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 2.
- K061054: Axiom Aristos FX Plus, Siemens Medical Solutions USA, Inc. (2006) Summary page 2.
- K021021: Modular Angiography System Axiom Artis, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K101491: Uroskop Omnia (2010), 11 descendants of its own

## Recalls of this device
- Dec 21, 2022 · Class II · Z-1166-2023: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
- Dec 21, 2022 · Class II · Z-1164-2023: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
- Apr 13, 2015 · Class II · Z-1668-2015: 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-0003-2015: 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 
- Aug 12, 2014 · Class II · Z-2649-2014: It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tablesi
- Jul 7, 2014 · Class II · Z-2292-2014: It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunct
- Apr 11, 2014 · Class II · Z-1711-2014: It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement
- Sep 3, 2013 · Class II · Z-0140-2014: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is no
- 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
- Aug 28, 2013 · Class II · Z-1845-2014: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examinat
- May 7, 2013 · Class II · Z-1848-2013: Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright 
- May 6, 2013 · Class II · Z-0016-2014: Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exis
- Feb 16, 2012 · Not classified · Z-1383-2012: During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibr
- 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
- Jan 14, 2011 · Not classified · Z-1421-2011: Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing
- Oct 25, 2010 · Not classified · Z-0717-2011: patient leg can be pinched
- Jul 13, 2010 · Not classified · Z-2222-2010: Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.
- Sep 19, 2008 · Not classified · Z-0327-2009: Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
- Sep 19, 2008 · Not classified · Z-0326-2009: Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.

## Indications for use
The AXTOM Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The AXIOM Iconos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). AXIOM Luminos dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.

Source page: https://510kreport.com/device/K062623
Methodology: https://510kreport.com/methodology