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FDA 510(k)

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories

K-Number: K171133 · 2017-07-11

ApplicantQfix
Decision Date2017-07-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K171133. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Qfix. The 510(k) number is K171133.

When did Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories receive FDA 510(k) clearance?

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171133.

Who is the listed applicant for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

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 Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories?

The FDA product code for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories is IYE.

Other records listing Qfix as applicant

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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