Cleared Traditional

K252579 - Orthoscan TAU MVP Mini C-Arm System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252579 · Ziehm-Orthoscan, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
152d
Days
Class 2
Risk

K252579 is an FDA 510(k) clearance for the Orthoscan TAU MVP Mini C-Arm System. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Ziehm-Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 14, 2026 after a review of 152 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ziehm-Orthoscan, Inc. devices

Submission Details

510(k) Number K252579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 107d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 80
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K252579.
OEC One CFD
K253269 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · Hefei Chimed Intelligent Machine Co., Ltd. · Nov 2025
Orthoscan TAU Mini C-Arm
K250587 · Ziehm-Orthoscan, Inc. · Jul 2025
Orthoscan VERSA Mini C-Arm
K243452 · Ziehm-Orthoscan, Inc. · Jan 2025
OEC One ASD
K240828 · Ge Hualun Medical Systems Co. , Ltd. · Dec 2024
OEC 3D
K233669 · Ge Oec Medical Systems, Inc. · Mar 2024