Sensus IORT System
K-Number: K182641 · 2019-02-21
ApplicantSensus Healthcare, Inc.
Decision Date2019-02-21
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sensus IORT System is a medical device manufactured by Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under approval number K182641. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sensus IORT System?
Sensus IORT System is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Sensus Healthcare, Inc.. The 510(k) number is K182641.
When was Sensus IORT System approved by the FDA?
Sensus IORT System received FDA 510(k) clearance on 2019-02-21, under approval number K182641.
What company makes Sensus IORT System?
Sensus IORT System is manufactured by Sensus Healthcare, Inc..
What is the FDA product code for Sensus IORT System?
The FDA product code for Sensus IORT System is JAD.
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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.