YSIO MAX
K133259SIEMENS MEDICAL SOLUTIONS USA, INC. · cleared 2014-01-24 · product code KPR · Radiology
Premarket evidence — what FDA accepted
source quote (p.2)
“The Ysio Max Radiography X-ray system is designed as a modular system with components such as ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and fixed integrated detectors, that may be combined into different configurations to meet specific customer needs. This feature, along with the AIM (Artificial Intelligence Mapping) feature is designed to calculate the shortest, fastest and safest path from one position to the next, in safe and efficient way.”
source quote (p.3)
“This feature, along with the AIM (Artificial Intelligence Mapping) feature is designed to calculate the shortest, fastest and safest path from one position to the next, in safe and efficient way.”
Validation studies (1)
Bench
sample size not stated
standards: IEC Standards, Voluntary Standards covering Electrical and Mechanical Safety
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).