Cleared Traditional

CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) (K082526) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082526 · Mri Cardiac Services, Incorporated · Radiology device
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Jan 2009
Decision
125d
Days
Class 2
Risk

K082526 is an FDA 510(k) clearance for the CARDIO VUE QUANTITATIVE ANALYSIS (CVQ). 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 Mri Cardiac Services, Incorporated (Winston-Salem, US). The FDA issued a Cleared decision on January 5, 2009 after a review of 125 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 Mri Cardiac Services, Incorporated devices

Submission Details

510(k) Number K082526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date January 05, 2009
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 757
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K082526.
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K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
INTEGRADWEB PACS SYSTEM
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GE ECHOPAC
K072952 · General Electric Co. · Nov 2007
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K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007