Cleared Traditional

YSIO X.pree

K233543 · Siemens Medical Solutions · Radiology
May 2024
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K233543 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 May 21, 2024, 200 days after receiving the submission on November 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K233543 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date May 21, 2024
Days to Decision 200 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

Similar Devices — KPR System, X-ray, Stationary

All 353
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
K250954 · Carestream Health · Jan 2026
uDR Arria & uDR Aris
K252000 · Shanghai United Imaging Healthcare Co., Ltd. · Nov 2025
uDR Aurora CX
K251167 · Shanghai United Imaging Healthcare Co., Ltd. · Sep 2025
Definium Tempo Select
K250788 · Ge Hualun Medical Systems Co. , Ltd. · Aug 2025
INNOVISION-DXII
K250790 · Dk Medical Systems Co., Ltd. · Aug 2025
YSIO X.pree
K250738 · Siemens Medical Solutions · Jul 2025