Cleared Traditional

Cios Alpha; Cios Flow

K251520 · Siemens Medical Solutions USA, Inc. · Radiology

Jul 2025

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K251520 is an FDA 510(k) clearance for the Cios Alpha; Cios Flow, 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 July 9, 2025, 54 days after receiving the submission on May 16, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251520 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2025
Decision Date	July 09, 2025
Days to Decision	54 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