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FDA 510(k)

Encompass 15 Channel Head Coil, 3T

K-Number: K190668 · 2019-09-09

ApplicantQfix
Decision Date2019-09-09
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Qfix. The 510(k) number is K190668.

When was Encompass 15 Channel Head Coil, 3T approved by the FDA?

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

What company makes Encompass 15 Channel Head Coil, 3T?

Encompass 15 Channel Head Coil, 3T is manufactured by Qfix.

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.

Other Devices by Qfix

K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories K182189Encompass SRS Headframe ; Encompass MR SRS Headframe K193243Alta Multipurpose Device K230312Iris AirShuttle™

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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