510(k) Report

FDA applicant

Indec Systems, Inc.

Santa Clara, CA3 decisions2003–20100 recalls

FDA records 3 decisions for Indec Systems, Inc. (Santa Clara, CA) from 2003 to 2010: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 9 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 Indec Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Indec Systems, 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, Radiological3decisions

Whose devices does it build on?

Its devices cite 9 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.

  • K092842EchoplaqueIndec Systems, Inc. · 20101cites it

What has FDA decided for it lately?

  • K092842EchoplaqueIndec Systems, Inc. · 2010
  • K062985Ivus EnhancerIndec Systems, Inc. · 2006
  • K024103Ivus PlusIndec Systems, Inc. · 2003

All 3 as Indec Systems, Inc. →