510(k) Report

FDA applicant

Medicatech USA

Irvine, CA10 decisions2008–20250 recalls

FDA records 10 decisions for Medicatech USA (Irvine, CA) from 2008 to 2025: 10 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 33 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medicatech USA, Inc.”.

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 Medicatech USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 22011: 32013: 12015: 12019: 12023: 12025: 1
2008high 3 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Medicatech USA by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medicatech USA’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?

  • KPRSystem, X-Ray, Stationary6decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)3decisions
  • OWBInterventional Fluoroscopic X-Ray System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 33 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 20112cite it
  • K080582Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA · 20082cite it
  • K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA · 20152cite it
  • K102284Krystalrad 560 (Flaatz 560)Medicatech USA · 20111cites it
  • K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA · 20131cites it

What has FDA decided for it lately?

  • K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)Medicatech USA, Inc. · 2025
  • K230918MasterX 800 SeriesMedicatech USA · 2023
  • K190601MasteRad MX30Medicatech USA · 2019
  • K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA · 2015
  • K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA · 2013
  • K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
  • K102284Krystalrad 560 (Flaatz 560)Medicatech USA · 2011
  • K102285Krystalrad (ATAL8)Medicatech USA · 2011

All 9 as Medicatech USA →The one decision as Medicatech USA, Inc. →