Cleared Traditional

K003437 - ODYSSEY LX, MODEL 211320

K003437 is an FDA 510(k) clearance for ODYSSEY LX, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003437 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
88d
Days
Class 2
Risk

K003437 is an FDA 510(k) clearance for the ODYSSEY LX, MODEL 211320. 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 (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on February 2, 2001 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.

FDA 510(k) Submission Details - K003437

510(k) Number K003437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date February 02, 2001
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K003437.
ADVANTAGE WINDOWS CT/PET FUSION
K010336 · Ge Medical Systems, Inc. · Feb 2001
ONYX-RAD TELEMEDICINE PACS
K003607 · Viztek, Inc. · Feb 2001
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
K003510 · Visualization Technology, Inc. · Feb 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · Philips Medical Systems North America, Inc. · Jan 2001
VIEW READING STATION
K003688 · Electromed Intl., Ltd. · Jan 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484 · Scimage, Inc. · Jan 2001
K003437 · ODYSSEY LX, MODEL 211320
Download PDF FDA Summary Philips Medical Syste…