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FDA 510(k)

FS-500DDR Medical Radiographic X-Ray System

N.º K: K152813 · 2016-12-02

SolicitanteOrich Medical Equipment (Tianjin) Co., Ltd.
Fecha de decisión2016-12-02
Código de productoKPR
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

FS-500DDR Medical Radiographic X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152813. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FS-500DDR Medical Radiographic X-Ray System?

FS-500DDR Medical Radiographic X-Ray System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. The 510(k) number is K152813.

When did FS-500DDR Medical Radiographic X-Ray System receive FDA 510(k) clearance?

FS-500DDR Medical Radiographic X-Ray System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152813.

Who is the listed applicant for FS-500DDR Medical Radiographic X-Ray System?

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

What is the FDA product code for FS-500DDR Medical Radiographic X-Ray System?

The FDA product code for FS-500DDR Medical Radiographic X-Ray System is KPR.

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Dispositivos relacionados (Código: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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.

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