YSIO X.pree

K233543

Siemens Medical Solutions · cleared 2024-05-21 · product code KPR · Radiology

FDA 510(k) summary for YSIO X.pree (K233543)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
0
Product code
KPR
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.6)
“The YSIO X.pree is a radiography X-ray system.”
AlgorithmAI-based Auto Cropping and a new algorithm for Auto Long-Leg/Full-Spine collimation, which is also used in the predicate MULTIX Impact.
source quote (p.8)
“AI-based Auto Cropping. Different. Changed to new algorithm, Auto Long-Leg/Full-Spine collimation added. The algorithm, used in MULTIX Impact, is also used for YSIO X.pree VA20”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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”

Validation studies (1)

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

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

11
recalls in product code, 24mo
42
MAUDE reports in code, 12mo
+16%
vs code's own 3-yr baseline
1
drift signals on this device
  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2022-03-07

    For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.

    recall event 89738 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2022-01-31

    Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.

    recall event 89703 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code KPR

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

uDR Aurora CX

K251167

Shanghai United Imaging Healthcare Co., Ltd.

cleared 2025-09-19

Definium Tempo Select

K250788

GE Hualun Medical Systems Co., Ltd

cleared 2025-08-28

YSIO X.pree

K250738

Siemens Medical Solutions

cleared 2025-07-31

Radiography 7300 C

K233662

Philips Medical Systems DMC GmbH

cleared 2024-06-13

YSIO MAX

K133259

SIEMENS MEDICAL SOLUTIONS USA, INC.

cleared 2014-01-24

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233543