FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) 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. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K221252.

When did Scivita 4KINSIGHT ICG Imaging System receive FDA 510(k) clearance?

Scivita 4KINSIGHT ICG Imaging System received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221252.

Who is the listed applicant for Scivita 4KINSIGHT ICG Imaging System?

The FDA 510(k) record lists Scivita Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.