Cleared Special

Orthoscan TAU Mini C-Arm

K250587 · Ziehm-Orthoscan, Inc. · Radiology

Jul 2025

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K250587 is an FDA 510(k) clearance for the Orthoscan TAU Mini C-Arm, 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 July 2, 2025, 125 days after receiving the submission on February 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K250587 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2025
Decision Date	July 02, 2025
Days to Decision	125 days
Submission Type	Special
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.