Philips Radiology Smart Assistant
K-Number: K212186 · 2021-12-13
ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2021-12-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Philips Radiology Smart Assistant is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2021-12-13 under approval number K212186. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Philips Radiology Smart Assistant?
Philips Radiology Smart Assistant is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K212186.
When was Philips Radiology Smart Assistant approved by the FDA?
Philips Radiology Smart Assistant received FDA 510(k) clearance on 2021-12-13, under approval number K212186.
What company makes Philips Radiology Smart Assistant?
Philips Radiology Smart Assistant is manufactured by Philips Medical Systems Dmc GmbH.
What is the FDA product code for Philips Radiology Smart Assistant?
The FDA product code for Philips Radiology Smart Assistant is KPR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.