Cleared Traditional

K142243 - LessRay with Tracking

K142243 is an FDA 510(k) clearance for LessRay with Tracking, manufactured by Saferay Spine, LLC. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K142243 · Saferay Spine, LLC · Radiology device
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Nov 2014
Decision
97d
Days
Class 2
Risk

K142243 is an FDA 510(k) clearance for the LessRay with Tracking. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Saferay Spine, LLC (Durham, US). The FDA issued a Cleared decision on November 18, 2014 after a review of 97 days - within the typical 510(k) review window.

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 Saferay Spine, LLC devices

FDA 510(k) Submission Details - K142243

510(k) Number K142243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date November 18, 2014
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 248
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