Cleared Traditional

K013426 - MOONRAY MOBILE C-ARM

K013426 is an FDA 510(k) clearance for MOONRAY MOBILE C-ARM, manufactured by Simad S.R.L.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K013426 · Simad S.R.L. · Radiology device
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Mar 2002
Decision
161d
Days
Class 2
Risk

K013426 is an FDA 510(k) clearance for the MOONRAY MOBILE C-ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Simad S.R.L. (Wilmington, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 161 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 Simad S.R.L. devices

FDA 510(k) Submission Details - K013426

510(k) Number K013426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2001
Decision Date March 26, 2002
Days to Decision 161 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
54d slower than avg
Panel avg: 107d · This submission: 161d
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 59
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K013426.
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