510(k) Report

FDA applicant

Neurophet., Inc.

Seoul, KR6 decisions2022–20260 recalls

FDA records 6 decisions for Neurophet., Inc. (Seoul, KR) from 2022 to 2026: 6 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 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 Neurophet., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12023: 12024: 12026 (partial year): 3
2022high 3 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Neurophet., Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neurophet., Inc.’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?

  • QIHAutomated Radiological Image Processing Software4decisions
  • LLZSystem, Image Processing, Radiological2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K221405Neurophet SCALE PETNeurophet., Inc. · 20222cite it
  • K242215Neurophet AQUA (V3.1)Neurophet., Inc. · 20242cite it
  • K220437Neurophet AQUANeurophet., Inc. · 20231cites it
  • K252496Neurophet AQUA AD PlusNeurophet., Inc. · 20261cites it

What has FDA decided for it lately?

  • K261273Neurophet AQUANeurophet., Inc. · 2026
  • K252563Neurophet SCALE PETNeurophet., Inc. · 2026
  • K252496Neurophet AQUA AD PlusNeurophet., Inc. · 2026
  • K242215Neurophet AQUA (V3.1)Neurophet., Inc. · 2024
  • K220437Neurophet AQUANeurophet., Inc. · 2023
  • K221405Neurophet SCALE PETNeurophet., Inc. · 2022

All 6 as Neurophet., Inc. →