Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories— 510(k) K171133
Substantially EquivalentQfix
FDA 510(k) clearance K171133 for Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories, Substantially Equivalent on 2017-07-11. Applicant: Qfix. Device class: 2.
Clearance details
- Applicant
- Qfix
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Avondale, PA, US
Recent devices under product code IYE
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- K190668 — Encompass 15 Channel Head Coil, 3T
- K182189 — Encompass SRS Headframe; Encompass MR SRS Headframe
- K160627 — Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.