Cleared Traditional

YSIO X.pree

K250738 · Siemens Medical Solutions · Radiology
Jul 2025
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K250738 is an FDA 510(k) clearance for the YSIO X.pree, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on July 31, 2025, 142 days after receiving the submission on March 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K250738 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2025
Decision Date July 31, 2025
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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