Cleared Special

K151486 - Biograph mCT and mCT Flow PET/CT Scanners

K151486 is an FDA 510(k) clearance for Biograph mCT and mCT Flow PET/CT Scanners, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 45-day FDA review.

K151486 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jul 2015
Decision
45d
Days
Class 2
Risk

K151486 is an FDA 510(k) clearance for the Biograph mCT and mCT Flow PET/CT Scanners. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 17, 2015 after a review of 45 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K151486

510(k) Number K151486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date July 17, 2015
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
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 364
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