510(k) Report

FDA applicant

Xoran Technologies, Inc.

Ann Arbor, MI7 decisions2003–20225 recalls

FDA records 7 decisions for Xoran Technologies, Inc. (Ann Arbor, MI) from 2003 to 2022: 7 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Xoran Technologies, LLC”.

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 Xoran Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12012: 12020: 12021: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2008: 22009: 12014: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed3decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • OWBInterventional Fluoroscopic X-Ray System1decision
  • KPRSystem, X-Ray, Stationary1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K061834Xcat; Xcat for NeuroXoran Technologies, Inc. · 20062cite it
  • K032243Minicat DentocatXoran Technologies, Inc. · 20032cite it
  • K113421MinicatXoran Technologies, Inc. · 20121cites it

What has FDA decided for it lately?

  • K221230TRONXoran Technologies, LLC · 2022
  • K210257Xoran Workstation, Model 10050Xoran Technologies, LLC · 2021
  • K201825MiniCAT 2DXoran Technologies, LLC · 2020
  • K113421MinicatXoran Technologies, Inc. · 20121 recall
  • K073306XoranconnectXoran Technologies, Inc. · 20081 recall
  • K061834Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006
  • K032243Minicat DentocatXoran Technologies, Inc. · 20033 recalls

All 4 as Xoran Technologies, Inc. →All 3 as Xoran Technologies, LLC →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K113421Xoran MiniCAT X-ray imaging deviceSep 8, 2014Class II
  • K073306XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based…Feb 3, 2009
  • K032243Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor…Sep 17, 2008
  • K032243Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MIJan 4, 2008
  • K032243Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This…Jul 13, 2006