510(k) Report

FDA applicant

Orthoscan, Inc.

Scottsdale, AZ6 decisions2001–20214 recalls

FDA records 6 decisions for Orthoscan, Inc. (Scottsdale, AZ) from 2001 to 2021: 6 510(k) clearances. Most are in product codes OXO (Image-Intensified Fluoroscopic X-Ray System…) and KQX (Goniometer, Ac-Powered). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Orthoscan , Ltd.”.

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

FDA decisions per year

1in 2021

2012: 12014: 12019: 12021: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2017

2017: 4
2007high 4 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Orthoscan, 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?

  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile5decisions
  • KQXGoniometer, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K113708Orthoscan Mobile DI Mini C-ArmOrthoscan, Inc. · 20124cite it
  • K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 20212cite it
  • K051754Orthoscan, Orthoscan HDOrthoscan, Inc. · 20051cites it
  • K133174Orthoscan FD Mini C-ArmOrthoscan, Inc. · 20141cites it
  • K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 20191cites it

What has FDA decided for it lately?

  • K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc. · 2021
  • K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc. · 2019
  • K133174Orthoscan FD Mini C-ArmOrthoscan, Inc. · 20141 recall
  • K113708Orthoscan Mobile DI Mini C-ArmOrthoscan, Inc. · 20121 recall
  • K051754Orthoscan, Orthoscan HDOrthoscan, Inc. · 20052 recalls
  • K011827Ortelius 800Orthoscan, Ltd. · 2001

All 5 as Orthoscan, Inc. →The one decision as Orthoscan, Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K113708Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with…Aug 31, 2017Class II
  • K051754Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with…Aug 31, 2017Class II
  • K051754Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with…Aug 31, 2017Class II
  • K133174Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with…Aug 31, 2017Class II