Cleared Special

K170904 - Biograph Horizon PET/CT

K170904 is the FDA 510(k) clearance for Biograph Horizon PET/CT by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Special 510(k) pathway after a 65-day FDA review.

K170904 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jun 2017
Decision
65d
Days
Class 2
Risk

K170904 is an FDA 510(k) clearance for the Biograph Horizon PET/CT. 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 June 1, 2017 after a review of 65 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

Submission Details

510(k) Number K170904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2017
Decision Date June 01, 2017
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K170904.
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Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
K162736 · Siemens Medical Solutions USA, Inc. · Oct 2016
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K162337 · Siemens Medical Solutions USA, Inc. · Sep 2016