Cleared Traditional

Ingenuity TF

K172406 · Philips Medical Systems (Cleveland), Inc. · Radiology
Oct 2017
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K172406 is an FDA 510(k) clearance for the Ingenuity TF, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on October 6, 2017, 58 days after receiving the submission on August 9, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K172406 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2017
Decision Date October 06, 2017
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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