Cleared Traditional

CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO (K905801) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905801 · Cemax, Inc. · Radiology device
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Mar 1991
Decision
84d
Days
Class 2
Risk

K905801 is an FDA 510(k) clearance for the CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO. 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. (Fremont, US). The FDA issued a Cleared decision on March 22, 1991 after a review of 84 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

Submission Details

510(k) Number K905801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1990
Decision Date March 22, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
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 770
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K905801.
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K904590 · Eastman Kodak Company · Nov 1990
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K903196 · General Electric Co. · Aug 1990