510(k) Report

FDA applicant

Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

El Marques, Queretaro, MX4 decisions2013–20200 recalls

FDA records 4 decisions for Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (El Marques, Queretaro, MX) from 2013 to 2020: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 39 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013: 12016: 12018: 12020: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions
  • KPRSystem, X-Ray, Stationary2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 39 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 20132cite it
  • K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 20181cites it

What has FDA decided for it lately?

  • K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2020
  • K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2018
  • K161518Pacs Core/EncoreCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2016
  • K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013

All 4 as Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. →