510(k) Report

FDA applicant

Hitachi, Ltd., Power Systems Group

Washington, DC2 decisions2006–20071 recall

FDA records 2 decisions for Hitachi, Ltd., Power Systems Group (Washington, DC) from 2006 to 2007: 2 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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., Power Systems Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hitachi, Ltd., Power Systems Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hitachi, Ltd., Power Systems Group’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

Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K053280ProbeatHitachi, Ltd., Power Systems Group · 20064cite it
  • K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 20073cite it

What has FDA decided for it lately?

  • K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 20071 recall
  • K053280ProbeatHitachi, Ltd., Power Systems Group · 2006

All 2 as Hitachi, Ltd., Power Systems Group →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073059PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a…Apr 21, 2015Class II

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