510(k) Report

FDA applicant

Medical IP Co., Ltd.

Jongno-Gu, KR2 decisions2019–20230 recalls

FDA records 2 decisions for Medical IP Co., Ltd. (Jongno-Gu, KR) from 2019 to 2023: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Its devices cite 3 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 Medical IP Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Medical IP Co., Ltd. by year, 2019–2026Sources: 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, Radiological1decision
  • QIHAutomated Radiological Image Processing Software1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K191026Medip ProMedical IP Co., Ltd. · 20191cites it
  • K223556DeepCatchMedical IP Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K223556DeepCatchMedical IP Co., Ltd. · 2023
  • K191026Medip ProMedical IP Co., Ltd. · 2019

All 2 as Medical IP Co., Ltd. →