Sentinel BreastScan II System
K-Number: K162767 · 2017-01-09
ApplicantFirst Sense Medical, LLC
Decision Date2017-01-09
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Sentinel BreastScan II System is a medical device manufactured by First Sense Medical, LLC. It received FDA 510(k) clearance on 2017-01-09 under approval number K162767. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentinel BreastScan II System?
Sentinel BreastScan II System is a medical device that received FDA 510(k) clearance on 2017-01-09. It is manufactured by First Sense Medical, LLC. The 510(k) number is K162767.
When was Sentinel BreastScan II System approved by the FDA?
Sentinel BreastScan II System received FDA 510(k) clearance on 2017-01-09, under approval number K162767.
What company makes Sentinel BreastScan II System?
Sentinel BreastScan II System is manufactured by First Sense Medical, LLC.
What is the FDA product code for Sentinel BreastScan II System?
The FDA product code for Sentinel BreastScan II System is LHQ.
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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.