Cleared Traditional

Orthoscan VERSA Mini C-Arm

K243452 · Ziehm-Orthoscan, Inc. · Radiology

Jan 2025

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K243452 is an FDA 510(k) clearance for the Orthoscan VERSA 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 January 14, 2025, 68 days after receiving the submission on November 7, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K243452 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2024
Decision Date	January 14, 2025
Days to Decision	68 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.