510(k) Report

FDA applicant

Etrauma.Com Corp.

Hopkonton, MA2 decisions2000–20044 recalls

FDA records 2 decisions for Etrauma.Com Corp. (Hopkonton, MA) from 2000 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. 4 recalls are 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 Etrauma.Com Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Etrauma.Com Corp. since 2007.

Recalls per year

4in 2016

2016: 4
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Etrauma.Com Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 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.

  • K994228Remoteimage SystemEtrauma.Com Corp. · 20001cites it

What has FDA decided for it lately?

  • K033825OrthopacsEtrauma.Com Corp. · 20044 recalls
  • K994228Remoteimage SystemEtrauma.Com Corp. · 2000

All 2 as Etrauma.Com Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K033825Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.Jan 31, 2016Class II
  • K033825Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI.…Jan 30, 2016Class II
  • K082144iConnect Access used with Merge PACS software provides medical specialists with access…Jan 30, 2016Class II
  • K082144iConnect Access used with Ortho PACS software provides medical specialists with access…Jan 30, 2016Class II