Cleared Traditional

IQon Spectral CT

K163711 · Philips Medical Systems (Cleveland), Inc. · Radiology
Apr 2017
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K163711 is an FDA 510(k) clearance for the IQon Spectral CT, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on April 5, 2017, 96 days after receiving the submission on December 30, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K163711 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2016
Decision Date April 05, 2017
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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