510(k) Report

FDA applicant

Scimage, Inc.

Los Altos, CA3 decisions1996–20080 recalls

FDA records 3 decisions for Scimage, Inc. (Los Altos, CA) from 1996 to 2008: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 4 predicates, 2 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 Scimage, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scimage, Inc.’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
  • LMDSystem, Digital Image Communications, Radiological1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K960911Netra Workstation System & Netra MD SoftwareScimage, Inc. · 19964cite it
  • K003484Netra Workstation and Netramd SoftwareScimage, Inc. · 20012cite it

What has FDA decided for it lately?

  • K073169Scimage PicomenterpriseScimage, Inc. · 2008
  • K003484Netra Workstation and Netramd SoftwareScimage, Inc. · 2001
  • K960911Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996

All 3 as Scimage, Inc. →