YSIO X.pree— 510(k) K250738

Name: FDA 510(k) clearance K250738
Creator: U.S. Food and Drug Administration
Published: 2025-07-31

Substantially Equivalent

Siemens Medical Solutions

FDA 510(k) clearance K250738 for YSIO X.pree, Substantially Equivalent on 2025-07-31. Applicant: Siemens Medical Solutions. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2025-03-11
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

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K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

Recent devices under product code KPR

More clearances from Siemens Medical Solutions

Adverse events under product code KPR