Cleared Traditional

K002590 - CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER

K002590 is an FDA 510(k) clearance for CEDARA CARDIOLOGY VIEWER, manufactured by Cedara Software Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K002590 · Cedara Software Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
71d
Days
Class 2
Risk

K002590 is an FDA 510(k) clearance for the CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER. 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 Cedara Software Corp. (Mississauga Ontario, CA). The FDA issued a Cleared decision on October 31, 2000 after a review of 71 days - a notably fast clearance 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 Cedara Software Corp. devices

FDA 510(k) Submission Details - K002590

510(k) Number K002590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date October 31, 2000
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1315
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K002590.
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · Philips Medical Systems North America, Inc. · Jan 2001
VIEW READING STATION
K003688 · Electromed Intl., Ltd. · Jan 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · Philips Medical Systems North America, Inc. · Dec 2000
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C · Oct 2000
VITREA 2, VERSION 2.1
K002519 · Vital Images, Inc. · Oct 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · Advanced Technology Laboratories, Inc. · Sep 2000