Cleared Abbreviated

K002685 - CORDLESS COMPACT MOBILE X-RAY SYSTEM

K002685 is an FDA 510(k) clearance for CORDLESS COMPACT MOBILE X-RAY SYSTEM, manufactured by Medison Radiology Systems, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Abbreviated 510(k) pathway after a 18-day FDA review.

K002685 · Medison Radiology Systems, Inc. · Radiology device
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Sep 2000
Decision
18d
Days
Class 2
Risk

K002685 is an FDA 510(k) clearance for the CORDLESS COMPACT MOBILE X-RAY SYSTEM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Medison Radiology Systems, Inc. (Deerfield,, US). The FDA issued a Cleared decision on September 15, 2000 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Medison Radiology Systems, Inc. devices

FDA 510(k) Submission Details - K002685

510(k) Number K002685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2000
Decision Date September 15, 2000
Days to Decision 18 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Standards-based clearance path.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 167
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