510(k) Report

FDA applicant

Ge Healthcare Dynamic Imaging Solutions

Monroe, CT2 decisions2008–200811 recalls

FDA records 2 decisions for Ge Healthcare Dynamic Imaging Solutions (Monroe, CT) in 2008: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 6 predicates, 0 of them its own earlier devices. 11 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 Ge Healthcare Dynamic Imaging Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2008: 2
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2023

2010: 42012: 12013: 12015: 12018: 12019: 12023: 2
2008high 4 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Dynamic Imaging Solutions by year, 2008–2026Sources: 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 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K083018Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 20083cite it
  • K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 20082cite it

What has FDA decided for it lately?

  • K083018Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 20084 recalls
  • K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 20087 recalls

All 2 as Ge Healthcare Dynamic Imaging Solutions →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K082318Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image…Sep 14, 2023Class II
  • K082318Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009…Mar 28, 2023Class II
  • K082318GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10…May 22, 2019Class II
  • K082318GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product…Feb 23, 2018Class II
  • K082318Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives…Sep 16, 2015Class II
  • K083018Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a…Feb 18, 2013Class II