Qfix: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Qfix” (first 2015, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Since 2017 the median was 85 days, against 89 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 109 |
| 2016 | 1 | 99 |
| 2017 | 1 | 85 |
| 2018 | 1 | 52 |
| 2019 | 1 | 178 |
| 2020 | 1 | 95 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 56 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qfix took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 6 | 6 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (7)
Most recent Qfix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230312 | Iris AirShuttle | IYE | 2023-03-31 | 56 |
| K193243 | Alta Multipurpose Device | IYE | 2020-02-28 | 95 |
| K190668 | Encompass 15 Channel Head Coil, 3T | MOS | 2019-09-09 | 178 |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | IYE | 2018-10-04 | 52 |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories | IYE | 2017-07-11 | 85 |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution | IYE | 2016-06-14 | 99 |
| 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 | 2015-12-04 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Qfix.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Qfix (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Qfix?
FDA lists 7 510(k) clearances under the applicant name “Qfix” (first 2015, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Qfix?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qfix is 95 days. Since 2017: 85 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Qfix?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 6); MOS (Coil, Magnetic Resonance, Specialty, 1).
Next steps
- See all 7 Qfix clearances with predicates and recalls
- Run predicate analysis for product code IYE, Qfix's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.