FDA 510(k)

Scivita 4KINSIGHT ICG Imaging System

K-번호: K221252 · 2023-01-13

결정일2023-01-13

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Scivita Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)K251338콜анг스코프 시각화 시스템 (일회용 비디오 콜анг스코프: SCV-P-01G, SCV-P-02G; Full HD 시각화 내시경 이미지 프로세서: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)K250210브론초 비디오스코프 시스템 (일회용 브론초 비디오스코프 (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD 비디오스코프 이미지 처리기 (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); 비디오스코프 이미지 처리기 (HDVS-S100A, HDVS-S100D))K240289フルHD内視鏡画像処理装置（HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D）K240192Single-use Extraction Baskets

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