Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Neurophet, Inc. with 6 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated May 15, 2026: Neurophet AQUA.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 15, 2026 | Neurophet AQUAK261273 · QIH | 510(k) clearances |
| May 15, 2026 | Neurophet SCALE PETK252563 · QIH | 510(k) clearances |
| May 15, 2026 | Neurophet AQUAK261273 · Radiology | AI-enabled devices |
| May 15, 2026 | Neurophet SCALE PETK252563 · Radiology | AI-enabled devices |
| Jan 29, 2026 | Neurophet AQUA AD PlusK252496 · QIH | 510(k) clearances |
| Jan 29, 2026 | Neurophet AQUA AD PlusK252496 · Radiology | AI-enabled devices |
| Oct 25, 2024 | Neurophet AQUA (V3.1)K242215 · QIH | 510(k) clearances |
| Oct 25, 2024 | Neurophet AQUA (V3.1)K242215 · Radiology | AI-enabled devices |
| May 10, 2023 | Neurophet AQUAK220437 · LLZ | 510(k) clearances |
| May 10, 2023 | Neurophet AQUAK220437 · Radiology | AI-enabled devices |
| Aug 5, 2022 | Neurophet SCALE PETK221405 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
