Cleared Special

K052897 - GE DEFINIUM AMX 700, MODEL AMX 700

K052897 is an FDA 510(k) clearance for GE DEFINIUM AMX 700, manufactured by General Electric Medical Systems. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 25-day FDA review.

K052897 · General Electric Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
25d
Days
Class 2
Risk

K052897 is an FDA 510(k) clearance for the GE DEFINIUM AMX 700, MODEL AMX 700. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by General Electric Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 8, 2005 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052897

510(k) Number K052897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date November 08, 2005
Days to Decision 25 days
Submission Type Special
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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 218
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K052897.
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
K062472 · Source-Ray, Inc. · Oct 2006
PULSERA
K061685 · Philips Medical Systems North America Co. · Sep 2006
MINXRAY, MODELS HFP24 AND HFP40
K060566 · Mikasa X-Ray Co., Ltd. · Apr 2006
MINXRAY, MODEL HF100H+
K052721 · Minxray, Inc. · Oct 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · Jpi America, Inc. · Oct 2005
MODEL SR-115 PORTABLE X-RAY SYSTEM
K052001 · Source-Ray, Inc. · Aug 2005
K052897 · GE DEFINIUM AMX 700, MODEL AMX 700
Download PDF FDA Summary General Electric Medi…