Cleared Traditional

K053194 - NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

K053194 is an FDA 510(k) clearance for NOGA XP CARDIAC NAVIGATION SYSTEM WITH ..., manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K053194 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
114d
Days
Class 2
Risk

K053194 is an FDA 510(k) clearance for the NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Palos Verdes Estates, US). The FDA issued a Cleared decision on March 9, 2006 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K053194

510(k) Number K053194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2005
Decision Date March 09, 2006
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K053194.
EP-WORKMATE
K063113 · Ep Medsystems · Oct 2006
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
K060954 · St. Jude Medical, Inc.-Endocardial Solutions · Apr 2006
INNOCOR
K051907 · Innovision A/S · Mar 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · Ge Healthcare · Jan 2006
MEDILOG DARWIN HOLTER ANALYSIS
K053369 · Huntleigh Healthcare · Dec 2005
K053194 · NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
Download PDF FDA Summary Biosense Webster, Inc.