510(k) Report

FDA applicant

Orfit Industries NV

Wijnegem, BE11 decisions1999–20200 recalls

FDA records 11 decisions for Orfit Industries NV (Wijnegem, BE) from 1999 to 2020: 11 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LHN (System, Radiation Therapy, Charged-Particle…). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Orfit Industries”.

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 Orfit Industries NV’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2013: 12014: 12015: 22016: 22017: 12019: 12020: 2
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orfit Industries NV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orfit Industries NV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical10decisions
  • LHNSystem, Radiation Therapy, Charged-Particle, Medical1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 54 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991319Raycast Immobilization Systems Hardware and Thermoplastic MaterialsOrfit Industries · 19992cite it
  • K191158The AIO SolutionOrfit Industries NV · 20192cite it
  • K151207Proton Immobilization SolutionOrfit Industries NV · 20151cites it
  • K131795Nanor and Efficast/Nanor Hybrid Thermoplastic MaterialsOrfit Industries NV · 20131cites it

What has FDA decided for it lately?

  • K202068The AIO Solution 3.0Orfit Industries NV · 2020
  • K200282Orfit Aerial CouchtopOrfit Industries NV · 2020
  • K191158The AIO SolutionOrfit Industries NV · 2019
  • K171734HP PRO Positioning DeviceOrfit Industries NV · 2017
  • K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV · 2016
  • K162862Raycast High Precision Lung Board SolutionOrfit Industries NV · 2016
  • K151946ThermofitOrfit Industries · 2015
  • K151207Proton Immobilization SolutionOrfit Industries NV · 2015

All 9 as Orfit Industries NV →All 2 as Orfit Industries →