FDA applicant

Hitachi Sales Corporation of America

Los Angeles, CA2 decisions1986–19860 recalls

FDA records 2 decisions for Hitachi Sales Corporation of America (Los Angeles, CA) in 1986: 2 510(k) clearances. Most are in product codes ISA (Massager, Therapeutic, Electric) and FLL (Continuous Measurement Thermometer). 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, physical medicine panel, where it files most

How often FDA has decided Hitachi Sales Corporation of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hitachi Sales Corporation of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hitachi Sales Corporation of America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hitachi Sales Corporation of America’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, Ltd. Radiation Oncology Systems, Kashiwanoha 2 Hitachi, Ltd., Power Systems Group 2

Hitachi Sales Corporation of America

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hitachi”