Cleared Traditional

Orthoscan TAU MVP Mini C-Arm System

K252579 · Ziehm-Orthoscan, Inc. · Radiology

Jan 2026

Decision

152d

Days

Class 2

Risk

About This 510(k) Submission

K252579 is an FDA 510(k) clearance for the Orthoscan TAU MVP Mini C-Arm System, a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Ziehm-Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 14, 2026, 152 days after receiving the submission on August 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K252579 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2025
Decision Date	January 14, 2026
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OXO — Image-intensified Fluoroscopic X-ray System, Mobile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Fluoroscopy Of The Human Body.