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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Biologics Consulting Group, Inc.
Calley Herzog

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K142243.
INFX-8000V with Wireless Footswitch
K143225 · Toshibamedical Systems Corporation · Jan 2015
EP NAVIGATOR REL. 5.0
K142126 · Philips Medical Systems Nederland B.V. · Dec 2014
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
K140041 · Genoray Co., Ltd. · Nov 2014
VERADIUS UNITY
K142708 · Philips Medical Systems Nethrlands BV · Oct 2014
ARTIS ZEE/ZEEGO SW VC21
K141574 · Siemens Medical Solutions USA, Inc. · Sep 2014
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
K141979 · Philips Medical Systems Netherland BV · Aug 2014
K142243 · LessRay with Tracking
Download PDF FDA Summary Saferay Spine, LLC