510(k) Report

FDA applicant

Sedecal., Sa.

Algete, ES26 decisions2002–202366 recalls

FDA records 26 decisions for Sedecal., Sa. (Algete, ES) from 2002 to 2023: 26 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 47 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 24 of them its own earlier devices. 66 recalls are 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 Sedecal., Sa.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009: 32011: 32012: 12013: 12014: 22016: 12018: 12019: 32020: 12021: 22022: 22023: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

46in 2025

2007: 22009: 12012: 12013: 12014: 32015: 22016: 12018: 22021: 12022: 12023: 32024: 12025: 46
2007high 46 (2025) · low 0 (2008)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • IZLSystem, X-Ray, Mobile17decisions
  • KPRSystem, X-Ray, Stationary6decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)3decisions

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 54 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 47 days; 5 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 41 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 64 times; 24 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.

  • K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 20048cite it
  • K133782Nova FA DR SystemSedecal., Sa. · 20145cite it
  • K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. · 20165cite it
  • K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 20095cite it
  • K062335Sedecal X Plus LP PlusSedecal., Sa. · 20065cite it
  • K090279Sedecal, Millennium PlusSedecal., Sa. · 20094cite it

What has FDA decided for it lately?

  • K232185SM-IVSedecal., Sa. · 2023
  • K222951SM-VSedecal., Sa. · 2022
  • K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa. · 20221 recall
  • K212291PhoenixSedecal., Sa. · 20211 recall
  • K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa. · 2021
  • K202293Radiographic System Challenge XSedecal., Sa. · 2020
  • K192936Soltus 500Sedecal., Sa. · 20191 recall
  • K192011PhoeniXSedecal., Sa. · 2019

All 26 as Sedecal., Sa. →

What has been recalled?

66 recalls linked to its devices; the latest:

  • K161345Model Number 40KW-FX.899, Mobile X-ray systemJun 10, 2025Class II
  • K161345Model Number 40KWFXPLUS-710CW, Mobile X-ray systemJun 10, 2025Class II
  • K090322Model Number 40KWMOBILE3.899, Mobile X-ray systemJun 10, 2025Class II
  • K090322Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemJun 10, 2025Class II
  • K090322Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemJun 10, 2025Class II
  • K090322Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemJun 10, 2025Class II

Other applicant names beginning “Sedecal.”

FDA records each applicant name separately; these may or may not be the same firm.

Sedecal USA, Inc. 3