# Qfix

- Location (FDA's records): Avondale, PA
- FDA decisions: 7 (2015–2023): 7 510(k) clearances
- Product codes: IYE (6), MOS (1)
- 510(k) review time since 2016: median 90 days, against 96 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diacor, Inc.: 1 (https://510kreport.com/company/diacor)
- Noras Mri Products GmbH: 1 (https://510kreport.com/company/noras-mri-products)
- Wfr/Aquaplast Corp.: 1 (https://510kreport.com/company/wfr-aquaplast)
- Medtec, Inc. D/B/A Civco Medical Solutions: 1 (https://510kreport.com/company/medtec-d-b-a-civco-medical-solutions)
- Macromedics BV: 1 (https://510kreport.com/company/macromedics)

## Its most-cited devices
- K160627: Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution (2016), cited by 1
- K152321: kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (2015), cited by 1

## Recent decisions
- K230312: Iris AirShuttle™ (Mar 31, 2023)
- K193243: Alta Multipurpose Device (Feb 28, 2020)
- K190668: Encompass 15 Channel Head Coil, 3T (Sep 9, 2019)
- K182189: Encompass SRS Headframe ; Encompass MR SRS Headframe (Oct 4, 2018)
- K171133: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (Jul 11, 2017)
- K160627: Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution (Jun 14, 2016)
- K152321: kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (Dec 4, 2015)

Source page: https://510kreport.com/company/qfix