# K121513: Multix Fusion

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solution
- Decided: Aug 10, 2012 after 81 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 4 (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). 64 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081722: YSIO, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K142049: Multix Fusion VA30 & VA40 (2014), 18 descendants of its own
- K162971: Multix Fusion Max (2016), 10 descendants of its own
- K182517: MULTIX Impact (2019), 8 descendants of its own
- K193089: MULTIX Impact (2020), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own

## Recalls of this device
- Aug 3, 2018 · Class II · Z-0297-2019: Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement i
- Aug 1, 2016 · Class II · Z-0013-2017: Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top t
- Aug 1, 2016 · Class II · Z-0014-2017: Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top t
- Feb 13, 2014 · Class II · Z-1505-2014: It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with t

## Indications for use
The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion system is not meant for mammography. The Multix Fusion uses a mobile (wired) or portable (wireless) digital detector for generating diagnostic images by converting x-rays into electronic signals. The Multix Fusion is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K121513
Methodology: https://510kreport.com/methodology