Cleared Traditional

K103678 - CASE CARDIAC TESTING SYSTEM

K103678 is an FDA 510(k) clearance for CASE CARDIAC TESTING SYSTEM, manufactured by Ge Medical Systems Information Technologies GmbH. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K103678 · Ge Medical Systems Information Technologies GmbH · Cardiovascular device
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Feb 2011
Decision
62d
Days
Class 2
Risk

K103678 is an FDA 510(k) clearance for the CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies GmbH (Freiburg,Baden Wurttemberg, DE). The FDA issued a Cleared decision on February 16, 2011 after a review of 62 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 GmbH devices

FDA 510(k) Submission Details - K103678

510(k) Number K103678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2010
Decision Date February 16, 2011
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 270
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