Cleared Traditional

K162736 - Biograph Horizon PET/CT and Biograph mC...

K162736 is the FDA 510(k) clearance for Biograph Horizon PET/CT and Biograph mC... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K162736 · Siemens Medical Solutions USA, Inc. · Radiology device
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Oct 2016
Decision
25d
Days
Class 2
Risk

K162736 is an FDA 510(k) clearance for the Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow 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 October 25, 2016 after a review of 25 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K162736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date October 25, 2016
Days to Decision 25 days
Submission Type Traditional
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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 242
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