Cleared Traditional

K170800 - NuVasive LessRay with Enhanced Tracking

K170800 is an FDA 510(k) clearance for NuVasive LessRay with Enhanced Tracking, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K170800 · Nu Vasive, Incorporated · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
154d
Days
Class 2
Risk

K170800 is an FDA 510(k) clearance for the NuVasive LessRay with Enhanced Tracking. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 154 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K170800

510(k) Number K170800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date August 18, 2017
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
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 298
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K170800.
Dynamic Coronary Roadmap 2.0
K172307 · Philips Medical Systems Nederland B.V. · Oct 2017
SyncVision System
K172574 · Volcano Corporation · Oct 2017
EndoNaut
K171829 · Therenva Sas · Sep 2017
OEC Elite
K171565 · Ge Oec Medical Systems, Inc. · Aug 2017
Ultimax-i, DREX-UI80 V1.60
K170832 · Toshibamedical Systems Corporation · Jul 2017
Infinix INFX-8000V, V6.40
K170909 · Toshiba Medical Systems Coroporation · Jun 2017