FDA 510(k)

Cocoon Portable Handheld X-Ray System

N.º K: K173046 · 2017-10-26

Fecha de decisión2017-10-26

Código de productoMUH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cocoon Portable Handheld X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K173046. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cocoon Portable Handheld X-Ray System?

Cocoon Portable Handheld X-Ray System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Dexcowin Co., Ltd.. The 510(k) number is K173046.

When did Cocoon Portable Handheld X-Ray System receive FDA 510(k) clearance?

Cocoon Portable Handheld X-Ray System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K173046.

Who is the listed applicant for Cocoon Portable Handheld X-Ray System?

The FDA 510(k) record lists Dexcowin Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cocoon Portable Handheld X-Ray System?

The FDA product code for Cocoon Portable Handheld X-Ray System is MUH.

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

Dispositivos relacionados (Código: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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.