Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
FDA 510(k) K171133 · Qfix
510(k) numberK171133
Submission
- Device name
- Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
- Applicant
- Qfix
Avondale, PA, US - Received
- April 17, 2017
- Decision date
- July 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories cleared by the FDA?
Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (K171133) received a 510(k) decision of Substantially Equivalent on July 11, 2017, 85 days after the submission was received.
What is the product code of K171133?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.