Cleared Special

K101013 - MODIFICATION TO SCINTRON IV

K101013 is the FDA 510(k) clearance for MODIFICATION TO SCINTRON IV by Miegmbh. It is a Class 2 Radiology device (product code KPS) cleared through the Special 510(k) pathway after a 56-day FDA review.

K101013 · Miegmbh · Radiology device
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Jun 2010
Decision
56d
Days
Class 2
Risk

K101013 is an FDA 510(k) clearance for the MODIFICATION TO SCINTRON IV. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Miegmbh (Elk Grove Village, US). The FDA issued a Cleared decision on June 7, 2010 after a review of 56 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 Miegmbh devices

Submission Details

510(k) Number K101013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date June 07, 2010
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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

All 243
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