510(k) Report

FDA applicant

Accuimage, Inc.

San Leandro, CA1 decision1996–19960 recalls

FDA records 1 decision for Accuimage, Inc. (San Leandro, CA) in 1996: 1 510(k) clearance. All are in product code LMD (System, Digital Image Communications…). Its devices cite 1 predicate, 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 Accuimage, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accuimage, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Accuimage, Inc. 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?

  • LMDSystem, Digital Image Communications, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 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.

  • K961023Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 199610cite it

What has FDA decided for it lately?

  • K961023Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996

The one decision as Accuimage, Inc. →

Other applicant names beginning “Accuimage”

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

Accuimage Diagnostics Corp. 3