Model note · X-ray
Siemens Healthineers Ysio Max Digital Radiography System
Ysio Max is a ceiling mounted stationary digital radiography room for whole body radiography and tomography of children, adults and bariatric patients, including emergency work. A Polydoros generator drives an OPTITOP tube on a ceiling rail with a motorised collimator, and fixed and wireless flat panel detectors feed the syngo FLC imaging system. It is not for mammography.
The model
Maker, model and type.
- Maker
- Siemens Healthcare GmbH (US: Siemens Medical Solutions USA, Inc.)
- Model
- Ysio Max Digital Radiography System
- Device type
- X-ray
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Generator and tube | Polydoros 65/80 kW generator; OPTITOP 150/40/80/HC-100 tube | Source |
| Collimation and dose | Digital multileaf collimator; Kerma X air kerma measurement | Source |
| Detectors | Trixell Pixium MAX wi-D (3543EZh) and MAX mini (2430EZ) wireless; MAX static (4343RC/RCE) fixed | Source |
| Fixed detector (4343RCE) | 2860 x 2874 pixels, 148 um pitch; a-Si with CsI; 16 bit; DQE 67% at 0.05 lp/mm; MTF 62% at 1 lp/mm | Source |
| Software (VF10) | Windows 10 based, added cybersecurity, extra paediatric programmes, virtual machine for hospital IT, Diamond View Plus processing for gridless exposures | Source |
| Model number | 10762470 | Source |
| FDA clearance | K181279 (June 2018, VF10), predicate K133259; product code KPR, Class II, 21 CFR 892.1680 | Source |
Recalls
Known FDA recalls.
- Z-2758-20202020-01-08
Software issues including incorrectly assigned images on Ysio Max and override collision risk on related systems.
FDA record - Z-1339-20202020-01-08
Software bug could assign one image to two patients.
FDA record - Z-0300-20192018-08-06
3D V tube stand lifting column cables could break without triggering the safety lock.
FDA record - Z-0015-20172016-08-01
Patient table internal part could detach and tilt the table top; use stopped pending inspection.
FDA record - Z-1667-20152015-04-13
VE10E: studies and images could be deleted; sporadic portable detector image recovery problems.
FDA record - Z-0994-20152014-12-15
VE10 with SmartOrtho: composed images could be flipped before sending to PACS.
FDA record - Z-0002-20152014-09-02
RIS worklist related malfunction could lose images on certain serial numbers.
FDA record
Safety
Safety warnings from the record.
Sources
Where this note comes from.
- FDA 510(k) K181279 summary, Ysio Max (VF10)
- openFDA recall search, Ysio Max
- openFDA MAUDE problem counts, Ysio Max
Not covered: Siemens operator and service documentation is not public, so there are no error codes, kV/mAs ranges, heat capacity, room dimensions or QA procedures. Recall records were read through openFDA.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.