FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Hitachi and its 13 subsidiaries with 179 510(k) clearances and 29 device recalls. The most recent is a 510(k) clearance dated Jun 11, 2026: PROBEAT-CR.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Hitachi and its 13 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 11, 2026 | PROBEAT-CRK260174 · LHN | 510(k) clearances |
| Jan 12, 2024 | PROBEAT-FRK232032 · LHN | 510(k) clearances |
| Dec 15, 2022 | Small Field ApplicatorK220883 · LHN | 510(k) clearances |
| Oct 7, 2021 | OASIS MRI SystemK211406 · LNH | 510(k) clearances |
| Nov 4, 2020 | Arietta 65K202422 · IYN | 510(k) clearances |
| Oct 21, 2020 | OASIS MRI SystemK202030 · LNH | 510(k) clearances |
| Jul 17, 2020 | SCENARIA ViewK200498 · JAK | 510(k) clearances |
| Jul 13, 2020 | PROBEAT-CRK201042 · LHN | 510(k) clearances |
| Aug 28, 2018 | VidiStar(TM) PACS & DICOM Viewer Software systemClass II · The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause interm | Device recalls |
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
