Cleared Traditional

K173816 - NM/CT 850

K173816 is the FDA 510(k) clearance for NM/CT 850 by Ge Healthcare. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K173816 · Ge Healthcare · Radiology device
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Apr 2018
Decision
123d
Days
Class 2
Risk

K173816 is an FDA 510(k) clearance for the NM/CT 850, NM/CT 860. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on April 17, 2018 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Healthcare devices

Submission Details

510(k) Number K173816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2017
Decision Date April 17, 2018
Days to Decision 123 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
16d slower than avg
Panel avg: 107d · This submission: 123d
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
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K173816.
HeartSee Cardiac P.E.T. Processing Software
K181343 · Bracco Diagnostics, Inc. · Jun 2018
Biograph Vision
K180811 · Siemens Medical Solutions USA, Inc. · May 2018
VERITON NM
K180514 · Spectrum Dynamics Medical, Ltd. · Apr 2018
uMI 780 PET/CT System
K172143 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2018
PET Digital Gating
K180318 · Ge Medical Systems, LLC · Apr 2018
ImagenUniversal
K173547 · Cardiovascular Imaging Technologies · Jan 2018