SmartCT R1.0
K-Number: K201583 · 2021-02-09
Decision Date2021-02-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SmartCT R1.0 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-02-09 under approval number K201583. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartCT R1.0?
SmartCT R1.0 is a medical device that received FDA 510(k) clearance on 2021-02-09. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K201583.
When was SmartCT R1.0 approved by the FDA?
SmartCT R1.0 received FDA 510(k) clearance on 2021-02-09, under approval number K201583.
What company makes SmartCT R1.0?
SmartCT R1.0 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for SmartCT R1.0?
The FDA product code for SmartCT R1.0 is OWB.
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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.