Cleared Traditional

ORTHOSCAN FD MINI C-ARM (K133174) - FDA 510(k) Clearance

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

K133174 · Orthoscan, Inc. · Radiology device
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Mar 2014
Decision
162d
Days
Class 2
Risk

K133174 is an FDA 510(k) clearance for the ORTHOSCAN FD MINI C-ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on March 28, 2014 after a review of 162 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 Orthoscan, Inc. devices

Submission Details

510(k) Number K133174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date March 28, 2014
Days to Decision 162 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 107d · This submission: 162d
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 28
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K133174.
Smart-C
K190024 · Turner Imaging Systems, Inc. · Sep 2019
OrthoScan TAU Mini C-Arm
K183220 · Orthoscan, Inc. · Jun 2019
OEC One
K182626 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2018
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · Hologic, Inc. · Apr 2012
ARCADIS AVANTIC
K051133 · Siemens Medical Solutions USA, Inc. · Jun 2005
SIREMOBILE C06
K040066 · Siemens Medical Solutions USA, Inc. · Feb 2004