Cleared Traditional

K130269 - ECAT SCINTRON PET

K130269 is the FDA 510(k) clearance for ECAT SCINTRON PET by Miegmbh. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K130269 · Miegmbh · Radiology device
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Apr 2013
Decision
74d
Days
Class 2
Risk

K130269 is an FDA 510(k) clearance for the ECAT SCINTRON PET. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Miegmbh (Seth, DE). The FDA issued a Cleared decision on April 19, 2013 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K130269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date April 19, 2013
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K130269.
CELESTEION, PCA-9000A/2
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SYMBIA
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BIOGRAPH MCT FAMILY
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OPTIMA NM/CT 640
K121019 · Ge Healthcare · Apr 2012
Q. FREEZE (MOTION VUE2)
K113408 · Ge Medical Systems, LLC · Feb 2012