Cleared Traditional

K083639 - MUSE CARDIOLOGY INFORMATION SYSTEM WITH...

K083639 is an FDA 510(k) clearance for MUSE CARDIOLOGY INFORMATION SYSTEM WITH..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K083639 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
70d
Days
Class 2
Risk

K083639 is an FDA 510(k) clearance for the MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on February 17, 2009 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K083639

510(k) Number K083639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date February 17, 2009
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 269
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K083639.
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · St Jude Medical · Oct 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · Biosense Webster, Inc. · Oct 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · St Jude Medical · May 2009
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · St Jude Medical · Sep 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · St Jude Medical · Dec 2007
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
K072202 · Biosense Webster, Inc. · Nov 2007