# K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Apr 2, 2018 after 129 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111292: Luminos Agile, Siemens Medical Solutions USA, Inc. (2011) Summary page 8.
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 8.
- K101491: Uroskop Omnia, Siemens Medical Solutions USA, Inc. (2010) Summary page 8.
- K152928: Multitom Rax, Siemens Medical Solutions USA, Inc. (2015) Summary page 8.

## Most influential descendants
- K250660: LUMINOS Q.namix T; LUMINOS Q.namix R (2025), 0 descendants of its own

## Recalls of this device
- Dec 5, 2025 · Class II · Z-0999-2026: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly 
- Jun 4, 2025 · Class II · Z-1982-2025: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Jun 4, 2025 · Class II · Z-1981-2025: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Jul 2, 2024 · Class II · Z-2526-2024: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
- Jul 2, 2024 · Class II · Z-2527-2024: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
- Jul 2, 2024 · Class II · Z-2525-2024: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
- Dec 21, 2022 · Class II · Z-1168-2023: 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-1165-2023: 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-1167-2023: 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 9, 2022 · Class II · Z-1002-2023: There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has m
- Nov 23, 2022 · Class II · Z-1481-2023: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient re
- Nov 23, 2022 · Class II · Z-1480-2023: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient re
- Nov 23, 2022 · Class II · Z-1479-2023: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient re
- Sep 9, 2020 · Class II · Z-0806-2021: After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long pe
- Jan 8, 2020 · Class II · Z-1337-2020: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
- Jan 8, 2020 · Class II · Z-1333-2020: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override f
- Jan 8, 2020 · Class II · Z-1332-2020: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override f
- Jan 8, 2020 · Class II · Z-2756-2020: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system und
- Jan 8, 2020 · Class II · Z-2757-2020: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system und
- Jan 8, 2020 · Class II · Z-1331-2020: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override f
- Jan 8, 2020 · Class II · Z-1338-2020: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
- Jan 8, 2020 · Class II · Z-2755-2020: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system und
- Feb 8, 2019 · Class II · Z-0985-2019: The swivel arm holding the monitors may become dislodged from the carrying arm.

## Indications for use
Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos Agile Max is not for mammography examinations. Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos dRF Max is not for mammography examinations. Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Multitom Rax is not for mammography examinations. Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract. The table supports endourological and minimal invasive surgery in urology as there are transurethral interventions (e.g. ureterorenoscopy (URS), double stent placement, cystoscopy, transurethral resection of bladder tumors (TURB), transurethral resection of the prostate (TURP)), percutaneous urological procedures (e.g. percutaneous nephrostomy (PCN), percutaneous nephrolitholapaxy (PCNL)), urological X-ray diagnosis (e.g. survey imaging of the kidney, ureter, and bladder (KUB), intravenous pyelogram (IVP), retrograde pyelography), micturition cystourethrogram (MCU), videourodynamics, laparoscopic procedures and minor open urological interventions. The system may be used on pediatric, adult and bariatric patients. Uroskop Omnia Max is not for mammography examinations.

Source page: https://510kreport.com/device/K173639
Methodology: https://510kreport.com/methodology