Cleared Abbreviated

K140138 - HEARTNAVIGATOR RELEASE 2.0

K140138 is the FDA 510(k) clearance for HEARTNAVIGATOR RELEASE 2.0 by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code OWB) cleared through the Abbreviated 510(k) pathway after a 139-day FDA review.

K140138 · Philips Medical Systems Nederland B.V. · Radiology device
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Jun 2014
Decision
139d
Days
Class 2
Risk

K140138 is an FDA 510(k) clearance for the HEARTNAVIGATOR RELEASE 2.0. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Lutz, US). The FDA issued a Cleared decision on June 10, 2014 after a review of 139 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 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

Submission Details

510(k) Number K140138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date June 10, 2014
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 239
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