Cleared Traditional

Philips CT Big Bore

K171850 · Philips Medical Systems (Cleveland), Inc. · Radiology
Nov 2017
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K171850 is an FDA 510(k) clearance for the Philips CT Big Bore, 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 November 9, 2017, 141 days after receiving the submission on June 21, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K171850 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2017
Decision Date November 09, 2017
Days to Decision 141 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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