Cleared Traditional

Philips Ingenuity CT

K160743 · Philips Medical Systems (Cleveland), Inc. · Radiology
Aug 2016
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K160743 is an FDA 510(k) clearance for the Philips Ingenuity 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 August 8, 2016, 144 days after receiving the submission on March 17, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K160743 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2016
Decision Date August 08, 2016
Days to Decision 144 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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