Cartesion Prime
K-Number: K191582 · 2019-08-13
ApplicantCanon Medical Systems Corporation
Decision Date2019-08-13
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Cartesion Prime is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-08-13 under approval number K191582. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cartesion Prime?
Cartesion Prime is a medical device that received FDA 510(k) clearance on 2019-08-13. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K191582.
When was Cartesion Prime approved by the FDA?
Cartesion Prime received FDA 510(k) clearance on 2019-08-13, under approval number K191582.
What company makes Cartesion Prime?
Cartesion Prime is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Cartesion Prime?
The FDA product code for Cartesion Prime is KPS.
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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.