Cleared Traditional

K031836 - PHILIPS FRESCO RELEASE 1

K031836 is an FDA 510(k) clearance for PHILIPS FRESCO RELEASE 1, manufactured by Philips Medical Systems North America Co.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K031836 · Philips Medical Systems North America Co. · Radiology device
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Aug 2003
Decision
62d
Days
Class 2
Risk

K031836 is an FDA 510(k) clearance for the PHILIPS FRESCO RELEASE 1. 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 Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on August 14, 2003 after a review of 62 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 Philips Medical Systems North America Co. devices

FDA 510(k) Submission Details - K031836

510(k) Number K031836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2003
Decision Date August 14, 2003
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 107d · This submission: 62d
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 1192
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K031836.
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
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HOLOGIC DR IMAGEPRO
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LCD MONITOR, RADIFORCE G11, G31, G51
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PHILIPS VIEWFORUM 2003
K032096 · Philips Medical Systems · Jul 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · Medison Co., Ltd. · Jun 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003