Cleared Special

K043441 - MIRAGE, RELEASE 5.5

K043441 is an FDA 510(k) clearance for MIRAGE, manufactured by Segami Corporation. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 30-day FDA review.

K043441 · Segami Corporation · Radiology device
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Jan 2005
Decision
30d
Days
Class 2
Risk

K043441 is an FDA 510(k) clearance for the MIRAGE, RELEASE 5.5. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Segami Corporation (Columbia, US). The FDA issued a Cleared decision on January 13, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Segami Corporation devices

FDA 510(k) Submission Details - K043441

510(k) Number K043441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2004
Decision Date January 13, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 326
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K043441.
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GE DISCOVERY VCT SYSTEM
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GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004
JETSTREAM WORKSPACE
K042880 · Adac Laboratories · Nov 2004