Cleared Traditional

K081556 - CADSTREAM, VERSION 5.0

K081556 is an FDA 510(k) clearance for CADSTREAM, manufactured by Confirma, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K081556 · Confirma, Inc. · Radiology device
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Feb 2009
Decision
244d
Days
Class 2
Risk

K081556 is an FDA 510(k) clearance for the CADSTREAM, VERSION 5.0. 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 Confirma, Inc. (Bellevue, US). The FDA issued a Cleared decision on February 2, 2009 after a review of 244 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-to-high 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 Confirma, Inc. devices

FDA 510(k) Submission Details - K081556

510(k) Number K081556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2008
Decision Date February 02, 2009
Days to Decision 244 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
137d slower than avg
Panel avg: 107d · This submission: 244d
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 1324
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081556.
NIO COLOR 3MP AND MDNC-3121
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K083673 · Carestream Health, Inc. · Dec 2008