Cleared Special

K043293 - MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K043293 · Acrorad Co., Ltd. · Radiology device
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Dec 2004
Decision
18d
Days
Class 2
Risk

K043293 is an FDA 510(k) clearance for the MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Acrorad Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 18 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 Acrorad Co., Ltd. devices

Submission Details

510(k) Number K043293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2004
Decision Date December 17, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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