Cleared Special

K162337 - Symbia 6.5

K162337 is the FDA 510(k) clearance for Symbia 6.5 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 17-day FDA review.

K162337 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 2016
Decision
17d
Days
Class 2
Risk

K162337 is an FDA 510(k) clearance for the Symbia 6.5. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 17 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 K162337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2016
Decision Date September 08, 2016
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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 K162337.
Biograph Horizon PET/CT
K170904 · Siemens Medical Solutions USA, Inc. · Jun 2017
Symbia Intevo Bold
K162483 · Siemens Medical Solutions USA, Inc. · Jan 2017
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
K162736 · Siemens Medical Solutions USA, Inc. · Oct 2016
Discovery MI
K161574 · Ge Medical Systems, LLC · Aug 2016
Discovery NM/CT 670 CZT
K153402 · Ge Healthcare · Jan 2016
Biograph Horizon PET/CT
K152880 · Siemens Medical Solutions USA, Inc. · Jan 2016