FDA 510(k)

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography

N.º K: K193225 · 2020-01-15

SolicitanteKonica Minolta Healthcare Americas, Inc.

Fecha de decisión2020-01-15

Código de productoKPR

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K193225. 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 KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography?

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K193225.

When did KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography receive FDA 510(k) clearance?

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography received FDA 510(k) clearance on 2020-01-15, under 510(k) number K193225.

Who is the listed applicant for KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography?

The FDA 510(k) record lists Konica Minolta Healthcare Americas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography?

The FDA product code for KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography is KPR.

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Otros registros que enlistan a Konica Minolta Healthcare Americas, Inc. como solicitante

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Dispositivos relacionados (Código: KPR)

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH Corporation K260488MULTIX 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

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