# K152928: Multitom Rax

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 13, 2015 after 39 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (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). 56 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 5.
- K061054: Axiom Aristos FX Plus, Siemens Medical Solutions USA, Inc. (2006) Summary page 5.

## 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
- K242948: Adora DRFi (04550010) (2024), 0 descendants of its own

## Recalls of this device
- Apr 20, 2021 · Class II · Z-1685-2021: Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for

## Indications for use
The Multitom Rax 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 Multitom Rax 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 unit may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA). The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. The Multitom Rax is not for mammography examinations

Source page: https://510kreport.com/device/K152928
Methodology: https://510kreport.com/methodology