# K212212: Multitom Rax with True2scale Body Scan Option

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Feb 18, 2022 after 218 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862120 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190373: SonialVision G4, Shimadzu Corporation (2019) Summary page 5.

## Most influential descendants
- K221281: Multitom Rax (2022), 0 descendants of its own

## Indications for use
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. The Multitom Rax is not for mammography examinations. The True2scale Body Scan functionality (ie., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan feature is not intended to be used for interventional purposes.

Source page: https://510kreport.com/device/K212212
Methodology: https://510kreport.com/methodology