InnoSight Diagnostic Ultrasound System
K-Number: K192254 · 2019-09-18
ApplicantQisda Corporation
Decision Date2019-09-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
InnoSight Diagnostic Ultrasound System is a medical device manufactured by Qisda Corporation. It received FDA 510(k) clearance on 2019-09-18 under approval number K192254. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InnoSight Diagnostic Ultrasound System?
InnoSight Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-09-18. It is manufactured by Qisda Corporation. The 510(k) number is K192254.
When was InnoSight Diagnostic Ultrasound System approved by the FDA?
InnoSight Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-09-18, under approval number K192254.
What company makes InnoSight Diagnostic Ultrasound System?
InnoSight Diagnostic Ultrasound System is manufactured by Qisda Corporation.
What is the FDA product code for InnoSight Diagnostic Ultrasound System?
The FDA product code for InnoSight Diagnostic Ultrasound System is IYN.
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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.