Cleared Traditional

K103565 - MEDVOXEL HEARTPRO SOFTWARE APPLICATION

K103565 is an FDA 510(k) clearance for MEDVOXEL HEARTPRO SOFTWARE APPLICATION, manufactured by Medvoxel Systems, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K103565 · Medvoxel Systems, Inc. · Radiology device
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Apr 2011
Decision
127d
Days
Class 2
Risk

K103565 is an FDA 510(k) clearance for the MEDVOXEL HEARTPRO SOFTWARE APPLICATION. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Medvoxel Systems, Inc. (Mississauga, CA). The FDA issued a Cleared decision on April 12, 2011 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Medvoxel Systems, Inc. devices

FDA 510(k) Submission Details - K103565

510(k) Number K103565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date April 12, 2011
Days to Decision 127 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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.

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All 1307
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