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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZL System, X-ray, Mobile

All 188
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K042866.
MODEL SR-115 PORTABLE X-RAY SYSTEM
K052001 · Source-Ray, Inc. · Aug 2005
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
K043062 · Source-Ray, Inc. · Dec 2004
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
K043002 · Sedecal., Sa. · Nov 2004
PRACTIX CONVENIO
K042368 · Philips Medical Systems North America Co. · Oct 2004
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
K042361 · Sedecal USA, Inc. · Sep 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004