Cleared Special

K033624 - PACS SOFTWARE SOLUTION 2003

K033624 is the FDA 510(k) clearance for PACS SOFTWARE SOLUTION 2003 by Canon USA, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 27-day FDA review.

K033624 · Canon USA, Inc. · Radiology device
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Dec 2003
Decision
27d
Days
Class 2
Risk

K033624 is an FDA 510(k) clearance for the PACS SOFTWARE SOLUTION 2003. 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 Canon USA, Inc. (San Diego, US). The FDA issued a Cleared decision on December 15, 2003 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Canon USA, Inc. devices

Submission Details

510(k) Number K033624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2003
Decision Date December 15, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033624.
COLOR LCD DISPLAY, MODEL RADIFORCE R22
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SIENET COSMOS
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HOLOGIC DR IMAGEPRO
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