510(k) Report

FDA applicant

Gmv Soluciones Globales Internet S.A.U.

Tres Cantos, ES4 decisions2014–20240 recalls

FDA records 4 decisions for Gmv Soluciones Globales Internet S.A.U. (Tres Cantos, ES) from 2014 to 2024: 4 510(k) clearances. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Gmv Soluciones Globales Internet S.A.U.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 12016: 12017: 12024: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Gmv Soluciones Globales Internet S.A.U. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gmv Soluciones Globales Internet S.A.U.’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?

  • MUJSystem, Planning, Radiation Therapy Treatment4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 80 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 20173cite it
  • K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 20141cites it
  • K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 20161cites it

What has FDA decided for it lately?

  • K233236Radiance V5Gmv Soluciones Globales Internet S.A.U. · 2024
  • K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
  • K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
  • K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014

All 4 as Gmv Soluciones Globales Internet S.A.U. →