Cleared Abbreviated

CARDIOMD-AC (K040616) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K040616 · Danish Diagnostic Development A/S · Radiology device
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Mar 2004
Decision
15d
Days
Class 2
Risk

K040616 is an FDA 510(k) clearance for the CARDIOMD-AC. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Danish Diagnostic Development A/S (Horsholm, DK). The FDA issued a Cleared decision on March 24, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Danish Diagnostic Development A/S devices

Submission Details

510(k) Number K040616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date March 24, 2004
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 159
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K040616.
GE DISCOVERY ST SYSTEM
K041220 · GE Medical Systems · Jun 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc. · Jul 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co. · Feb 2003