Cleared Traditional

ArmSure Fluoroscopic Positioning System

K251992 · Savfe Co. , Ltd. · Radiology

Feb 2026

Decision

229d

Days

Class 2

Risk

About This 510(k) Submission

K251992 is an FDA 510(k) clearance for the ArmSure Fluoroscopic Positioning System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Savfe Co. , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on February 11, 2026, 229 days after receiving the submission on June 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251992 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	February 11, 2026
Days to Decision	229 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