510(k) Report

FDA applicant

Minxray, Inc.

Northbrook, IL18 decisions1976–20210 recalls

FDA records 18 decisions for Minxray, Inc. (Northbrook, IL) from 1976 to 2021: 18 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 46 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 11 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 Minxray, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 12010: 22014: 12016: 12017: 12018: 12019: 12020: 12021: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Minxray, Inc.’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?

  • IZLSystem, X-Ray, Mobile15decisions
  • EHDUnit, X-Ray, Extraoral With Timer2decisions
  • IZHSystem, X-Ray, Mammographic1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 31 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 46 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 11 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.

  • K182207TR90BHMinxray, Inc. · 20189cite it
  • K052721Minxray, Model HF100H+Minxray, Inc. · 20055cite it
  • K040046Minxray, Model HF120/60H PowerplusMinxray, Inc. · 20045cite it
  • K191451CMDR 2CW (Multiple models)Minxray, Inc. · 20192cite it
  • K973712Minxray HF100H High Frequency Diagnostic X-Ray UnitMinxray, Inc. · 19972cite it
  • K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 20161cites it

What has FDA decided for it lately?

  • K210479IMPACT and X-RangerMinxray, Inc. · 2021
  • K201575CMDR 2C (Multiple Models)Minxray, Inc. · 2020
  • K191451CMDR 2CW (Multiple models)Minxray, Inc. · 2019
  • K182207TR90BHMinxray, Inc. · 2018
  • K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
  • K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
  • K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
  • K091255Minxray, Model: BPD60Minxray, Inc. · 2010

All 18 as Minxray, Inc. →