Cleared Traditional

K042866 - AMX5 AND AMX5D MOBILE X-RAY SYSTEMS

K042866 is an FDA 510(k) clearance for AMX5 AND AMX5D MOBILE X-RAY SYSTEMS, manufactured by Ge Healthcare Technologies. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K042866 · Ge Healthcare Technologies · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
15d
Days
Class 2
Risk

K042866 is an FDA 510(k) clearance for the AMX5 AND AMX5D MOBILE X-RAY SYSTEMS. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Ge Healthcare Technologies (Milwaukee, US). The FDA issued a Cleared decision on November 2, 2004 after a review of 15 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Healthcare Technologies devices

FDA 510(k) Submission Details - K042866

510(k) Number K042866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date November 02, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 133
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K042866.
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · Siemens Medical Solutions USA, Inc. · May 2007
PULSERA
K061685 · Philips Medical Systems North America Co. · Sep 2006
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
K043002 · Sedecal., Sa. · Nov 2004
PRACTIX CONVENIO
K042368 · Philips Medical Systems North America Co. · Oct 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · Shimadzu Corp. · Jul 2004