FDA 510(k)

Sistema de Ultrasonido Diagnóstico ACUSON S1000 / S2000 / S3000

N.º K: K162243 · 2016-09-06

SolicitanteSiemens Medi Cal Solutions, Inc.

Fecha de decisión2016-09-06

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K162243. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System?

ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K162243.

When did ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-06, under 510(k) number K162243.

Who is the listed applicant for ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System?

The FDA product code for ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System is IYN.

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 Siemens Medi Cal Solutions, Inc. como solicitante

K193216syngo.CT Lung CAD K182639MOBILETT Elara Max K182517MULTIX Impact K181279Ysio Max K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax K173408Mammomat Revelation

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: IYN)

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.