510(k) Report

FDA applicant

Array Corp.

Tokyo, JP3 decisions1998–20060 recalls

FDA records 3 decisions for Array Corp. (Tokyo, JP) from 1998 to 2006: 3 510(k) clearances. All are in product code LMA (Digitizer, Image, Radiological). 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 Array Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Array Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Array Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LMADigitizer, Image, Radiological3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K982785Film Digitizer Model 2905Array Corp. · 19981cites it

What has FDA decided for it lately?

  • K063424Film Digitzer, Model 2908 Mammo ProArray Corp. · 2006
  • K033637Medical Image Digitizer, Model 2908Array Corp. · 2003
  • K982785Film Digitizer Model 2905Array Corp. · 1998

All 3 as Array Corp. →

Other applicant names beginning “Array”

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

Array Medical, Inc. 3