Cleared Traditional

K904519 - AGFA DIAGNOSTIC CENTER (ADC)

K904519 is an FDA 510(k) clearance for AGFA DIAGNOSTIC CENTER (ADC), manufactured by Enhanced Imaging Technologies, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K904519 · Enhanced Imaging Technologies, Inc. · Radiology device
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Jun 1991
Decision
261d
Days
Class 2
Risk

K904519 is an FDA 510(k) clearance for the AGFA DIAGNOSTIC CENTER (ADC). 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 Enhanced Imaging Technologies, Inc. (Ridgefield Park, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 261 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 Enhanced Imaging Technologies, Inc. devices

FDA 510(k) Submission Details - K904519

510(k) Number K904519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1990
Decision Date June 21, 1991
Days to Decision 261 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 107d · This submission: 261d
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 2086
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