Cleared Special

K162990 - Optima XR240amx

K162990 is the FDA 510(k) clearance for Optima XR240amx by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code IZL) cleared through the Special 510(k) pathway after a 19-day FDA review.

K162990 · Ge Medical Systems, LLC · Radiology device
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Nov 2016
Decision
19d
Days
Class 2
Risk

K162990 is an FDA 510(k) clearance for the Optima XR240amx. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on November 15, 2016 after a review of 19 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.

View all Ge Medical Systems, LLC devices

Submission Details

510(k) Number K162990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2016
Decision Date November 15, 2016
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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