FDA 510(k)

Encompass 15 Channel Head Coil, 3T

Número K: K190668 · 2019-09-09

RequerenteQfix

Data da decisão2019-09-09

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Encompass 15 Channel Head Coil, 3T is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K190668. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Encompass 15 Channel Head Coil, 3T?

Encompass 15 Channel Head Coil, 3T is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is Qfix. The 510(k) number is K190668.

When did Encompass 15 Channel Head Coil, 3T receive FDA 510(k) clearance?

Encompass 15 Channel Head Coil, 3T received FDA 510(k) clearance on 2019-09-09, under 510(k) number K190668.

Who is the listed applicant for Encompass 15 Channel Head Coil, 3T?

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

What is the FDA product code for Encompass 15 Channel Head Coil, 3T?

The FDA product code for Encompass 15 Channel Head Coil, 3T is MOS.

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Outros registros que listam Qfix como candidato(a)

K230312Iris AirShuttle™K193243Dispositivo Multipropósito Alta K182189Encompass SRS Headframe ; Encompass MR SRS Headframe K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution

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