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FDA 510(k)

Sistema de Radiografia Digital AAU Médico Amrad; Sistema de Radiografia Digital AAU Plus Médico Amrad; Sistema de Radiografia Digital DFMT Médico Amrad; Sistema de Radiografia Digital FMT Médico Amrad

Número K: K173823 · 2018-02-09

RequerenteSummit Industries, LLC
Data da decisão2018-02-09
Código do produtoKPR
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Summit Industries, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K173823. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Summit Industries, LLC. The 510(k) number is K173823.

When did Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System receive FDA 510(k) clearance?

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System received FDA 510(k) clearance on 2018-02-09, under 510(k) number K173823.

Who is the listed applicant for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

The FDA 510(k) record lists Summit Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System?

The FDA product code for Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System is KPR.

Ensaios clínicos relacionados

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Outros registros que listam Summit Industries, LLC como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K153119Sistema de Radiografia Digital OTS Médico Amrad, Sistema de Radiografia Digital DFMTS Médico Amrad, Sistema de Radiografia Digital FRS Médico Amrad

Dispositivos Relacionados (Código: KPR)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Fonte oficial

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