Cleared Traditional

K133174 - ORTHOSCAN FD MINI C-ARM

K133174 is an FDA 510(k) clearance for ORTHOSCAN FD MINI C-ARM, manufactured by Orthoscan, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K133174

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
Combination Product No
PCCP Authorized No
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.

OXO Device Classification - Class 2, Special Controls

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 69
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