FDA applicant

Hitachi Ltd. Healthcare Hitachi Works

Hitachi, JP1 decision2018–20180 recalls

FDA records 1 decision for Hitachi Ltd. Healthcare Hitachi Works (Hitachi, JP) in 2018: 1 510(k) clearance. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 2 predicates, 0 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 Hitachi Ltd. Healthcare Hitachi Works’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Hitachi Ltd. Healthcare Hitachi Works by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hitachi Ltd. Healthcare Hitachi Works’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Hitachi”

FDA records each applicant name separately; these may or may not be the same firm.

Hitachi Medical Systems America, Inc. 100 Hitachi Medical Corp. of America 32 Hitachi Healthcare Americas 17 Hitachi Chemical Diagnostics, Inc. 16 Hitachi Medical Corp. 12 Hitachi, Ltd. 8 Hitachi Aloka Medical, Ltd. 6 Hitachi, Ltd., Health Care Company 4 Hitachi Aloka Medical America, Inc. 3 Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical 3 Hitachi Sales Corporation of America 2 Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 2

Hitachi Ltd. Healthcare Hitachi Works

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Hitachi”