FDA 510(k)

Scivita 4KINSIGHT ICG Imaging System

N.º K: K221252 · 2023-01-13

SolicitanteScivita Medical Technology Co., Ltd.

Fecha de decisión2023-01-13

Código de productoGCJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.