# K133259: Ysio Max

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 24, 2014 after 93 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 7 (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.
23 later devices descend from it; 2 cite it directly.
0 of 88 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
- Jan 8, 2020 · Class II · Z-2758-2020: 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-1339-2020: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
- Aug 6, 2018 · Class II · Z-0300-2019: In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This coul
- Aug 1, 2016 · Class II · Z-0015-2017: 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
- Apr 13, 2015 · Class II · Z-1667-2015: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image rec
- Dec 15, 2014 · Class II · Z-0994-2015: Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. l
- Sep 2, 2014 · Class II · Z-0002-2015: Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers 

## Indications for use
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic 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 Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K133259
Methodology: https://510kreport.com/methodology