Cleared Traditional

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) (K864519) - FDA 510(k) Clearance

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

K864519 · Parexel Intl. Corp. · Radiology device
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Feb 1987
Decision
88d
Days
Class 2
Risk

K864519 is an FDA 510(k) clearance for the PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR). 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 Parexel Intl. Corp. (Cambridge, US). The FDA issued a Cleared decision on February 13, 1987 after a review of 88 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 Parexel Intl. Corp. devices

Submission Details

510(k) Number K864519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date February 13, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
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 768
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K864519.
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K864739 · Eastman Kodak Company · Feb 1987
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K864927 · Eastman Kodak Company · Feb 1987
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K863132 · General Electric Co. · Jan 1987