# K221281: Multitom Rax

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Nov 17, 2022 after 198 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: 9 generations back to K862120 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212212: Multitom Rax with True2scale Body Scan Option, Siemens Medical Solutions (2022) Summary page 5.

## Recalls of this device
- Jul 2, 2024 · Class II · Z-2528-2024: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

## 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 True2scale Body Scan functionality (i.e., 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 is not intended to be used for interventional purposes. The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m. Multitom Rax is not for mammography examinations.

Source page: https://510kreport.com/device/K221281
Methodology: https://510kreport.com/methodology