Cleared Traditional

K032531 - CHASE CARDIAC ANALYSIS SYSTEM

K032531 is the FDA 510(k) clearance for CHASE CARDIAC ANALYSIS SYSTEM by Chase Medical, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K032531 · Chase Medical, Inc. · Radiology device
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Feb 2004
Decision
171d
Days
Class 2
Risk

K032531 is an FDA 510(k) clearance for the CHASE CARDIAC ANALYSIS SYSTEM. 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 Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on February 2, 2004 after a review of 171 days - an extended review cycle.

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 Chase Medical, Inc. devices

Submission Details

510(k) Number K032531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2003
Decision Date February 02, 2004
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 107d · This submission: 171d
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 1147
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K032531.
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SIENET COSMOS
K033831 · Siemens AG Medical Solutions · Dec 2003
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K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003