510(k) Report

FDA applicant

Dome Imaging Systems, Inc.

Waltham, MA2 decisions1999–20040 recalls

FDA records 2 decisions for Dome Imaging Systems, Inc. (Waltham, MA) from 1999 to 2004: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 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 Dome Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dome Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dome Imaging Systems, 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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K040443Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 20041cites it
  • K983815PacscacheDome Imaging Systems, Inc. · 19991cites it

What has FDA decided for it lately?

  • K040443Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004
  • K983815PacscacheDome Imaging Systems, Inc. · 1999

All 2 as Dome Imaging Systems, Inc. →