Cleared Traditional

Philips Radiology Smart Assistant

K212186 · Philips Medical Systems Dmc GmbH · Radiology
Dec 2021
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K212186 is an FDA 510(k) clearance for the Philips Radiology Smart Assistant, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on December 13, 2021, 153 days after receiving the submission on July 13, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K212186 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2021
Decision Date December 13, 2021
Days to Decision 153 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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