Cleared Abbreviated

K172307 - Dynamic Coronary Roadmap 2.0

K172307 is an FDA 510(k) clearance for Dynamic Coronary Roadmap 2.0, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code OWB cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K172307 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
85d
Days
Class 2
Risk

K172307 is an FDA 510(k) clearance for the Dynamic Coronary Roadmap 2.0. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on October 24, 2017 after a review of 85 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nederland B.V. devices

FDA 510(k) Submission Details - K172307

510(k) Number K172307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date October 24, 2017
Days to Decision 85 days
Submission Type Abbreviated
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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 293
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K172307.
LessRay System
K173314 · Nu Vasive, Incorporated · Nov 2017
OEC One
K172700 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2017
XIDF-AWS801, Angio Workstation, V7.0
K172646 · Toshibamedical Systems Corporation · Oct 2017
SyncVision System
K172574 · Volcano Corporation · Oct 2017
EndoNaut
K171829 · Therenva Sas · Sep 2017
NuVasive LessRay with Enhanced Tracking
K170800 · Nu Vasive, Incorporated · Aug 2017