510(k) Report

FDA applicant

Qfix

Avondale, PA7 decisions2015–20230 recalls

FDA records 7 decisions for Qfix (Avondale, PA) from 2015 to 2023: 7 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Qfix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12016: 12017: 12018: 12019: 12020: 12023: 1
2015high 1 (2015) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Qfix by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical6decisions
  • MOSCoil, Magnetic Resonance, Specialty1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony…Qfix · 20161cites it
  • K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI…Qfix · 20151cites it

What has FDA decided for it lately?

  • K230312Iris AirShuttle™Qfix · 2023
  • K193243Alta Multipurpose DeviceQfix · 2020
  • K190668Encompass 15 Channel Head Coil, 3TQfix · 2019
  • K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeQfix · 2018
  • K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix · 2017
  • K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony…Qfix · 2016
  • K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI…Qfix · 2015

All 7 as Qfix →