510(k) Report

FDA applicant

Idx Systems Corp.

North Attleboro, MA2 decisions1996–20052 recalls

FDA records 2 decisions for Idx Systems Corp. (North Attleboro, MA) from 1996 to 2005: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Idx Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Idx Systems Corp. since 2007.

Recalls per year

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Idx Systems Corp. 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, Radiological1decision
  • 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:

What has FDA decided for it lately?

  • K052618Imagecast PacsIdx Systems Corp. · 20052 recalls
  • K954071IdxviewIdx Systems Corp. · 1996

All 2 as Idx Systems Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K052618Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product…Feb 18, 2013Class II
  • K052618Imagecast PACS is an image management system intended to be used by trained…Mar 4, 2011Class II