YSIO X.pree
K233543Siemens Medical Solutions · cleared 2024-05-21 · product code KPR · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an 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. AI-based Auto Cropping. AI based Automatic collimation.”
source quote (p.8)
“AI-based Auto Cropping. AI based Automatic collimation. The algorithm, used in MULTIX Impact, is also used for YSIO X.pree VA20”
source quote (p.12)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission - Guidance for Industry and Food and Drug Administration Staff Document Issued on September 27, 2023”
Validation studies (2)
Retrospective clinical
sample size not stated · 1 site(s)
endpoints: System function and performance-related clinical workflow; Image quality; Ease of use; Overall performance and stability
Bench
sample size not stated
standards: ANSI AAMI 60601-1, 2012 Ed. 3.1, IEC 60601-1-2 2014 Ed 4.1, IEC 60601-1-3: Edition 2.1, 2013, IEC 60601-2-28, 2017, IEC 60601-2-54 2018, Edition 1.2, IEC 60601-1-6 2020 Ed 3.2, IEC 62366-1 2020 Ed 1.1, ISO 14971: 2019, IEC 62304 2015, Ed.1.1, IEC 61910-1: 2014, Ed 1.0, NEMA PS 3.1 - 3.20 2021, ISO EN ISO 10993-1 Fifth edition 2018
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250738 (decision 2025-07-31) from Siemens Medical Solutions for a matching device line ("YSIO X.pree") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250738
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).