Cleared Traditional

Cios Select

Nov 2025
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K250241 is an FDA 510(k) clearance for the Cios Select, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on November 4, 2025, 281 days after receiving the submission on January 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K250241 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date November 04, 2025
Days to Decision 281 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OWB — Interventional Fluoroscopic X-ray System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy

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