Cleared Abbreviated

ADVANTAGE PADDLE (K033202) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K033202 · Livingston Products, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
62d
Days
Class 2
Risk

K033202 is an FDA 510(k) clearance for the ADVANTAGE PADDLE. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Livingston Products, Inc. (Deer Field, US). The FDA issued a Cleared decision on December 3, 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 892.1710 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Livingston Products, Inc. devices

Submission Details

510(k) Number K033202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date December 03, 2003
Days to Decision 62 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K033202.
SMART FINDER
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OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996