Cleared Traditional

K880169 - CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION

K880169 is an FDA 510(k) clearance for CEMAX 5000 MULTIDIMENSIONAL IMAGING WOR..., manufactured by Cemax, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K880169 · Cemax, Inc. · Radiology device
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Mar 1988
Decision
54d
Days
Class 2
Risk

K880169 is an FDA 510(k) clearance for the CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION. 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 Cemax, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 54 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 Cemax, Inc. devices

FDA 510(k) Submission Details - K880169

510(k) Number K880169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date March 09, 1988
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
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 2066
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K880169.
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