Qfix
Avondale, PA, US
Qfix appears in FDA device records in Avondale, PA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Qfix between 2015 and 2023. The busiest year on record is 2015, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230312 | Iris AirShuttle™ | IYE | Substantially Equivalent | |
| K193243 | Alta Multipurpose Device | IYE | Substantially Equivalent | |
| K190668 | Encompass 15 Channel Head Coil, 3T | MOS | Substantially Equivalent | |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | IYE | Substantially Equivalent | |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories | IYE | Substantially Equivalent | |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution | IYE | Substantially Equivalent | |
| 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 | IYE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain