FDA 510(k)

Scivita 4KINSIGHT ICG Imaging System

K-Nummer: K221252 · 2023-01-13

AntragstellerScivita Medical Technology Co., Ltd.

Entscheidungsdatum2023-01-13

ProduktcodeGCJ

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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