FDA 510(k)

Sistema de Visualización 3D

N.º K: K183675 · 2019-09-25

SolicitanteScivita Medical Technology Co., Ltd.

Fecha de decisión2019-09-25

Código de productoGCJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

3D Visualization 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 2019-09-25 under 510(k) number K183675. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3D Visualization System?

3D Visualization System is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K183675.

When did 3D Visualization System receive FDA 510(k) clearance?

3D Visualization System received FDA 510(k) clearance on 2019-09-25, under 510(k) number K183675.

Who is the listed applicant for 3D Visualization 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 3D Visualization System?

The FDA product code for 3D Visualization System is GCJ.

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Otros registros que enlistan a Scivita Medical Technology Co., Ltd. como solicitante

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: 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.)K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)K240192Single-use Extraction Baskets

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Fuente oficial

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