Scivita 4KINSIGHT ICG Imaging System
K-Number: K221252 · 2023-01-13
ApplicantScivita Medical Technology Co., Ltd.
Decision Date2023-01-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Scivita 4KINSIGHT ICG Imaging System is a medical device manufactured by Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval number K221252. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Scivita 4KINSIGHT ICG Imaging System?
Scivita 4KINSIGHT ICG Imaging System is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Scivita Medical Technology Co., Ltd.. The 510(k) number is K221252.
When was Scivita 4KINSIGHT ICG Imaging System approved by the FDA?
Scivita 4KINSIGHT ICG Imaging System received FDA 510(k) clearance on 2023-01-13, under approval number K221252.
What company makes Scivita 4KINSIGHT ICG Imaging System?
Scivita 4KINSIGHT ICG Imaging System is manufactured by Scivita Medical Technology Co., Ltd..
What is the FDA product code for Scivita 4KINSIGHT ICG Imaging System?
The FDA product code for Scivita 4KINSIGHT ICG Imaging System is GCJ.
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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.