510(k) Report

FDA applicant

Diagnosoft, Inc.

North Attleboro, MA3 decisions2006–20110 recalls

FDA records 3 decisions for Diagnosoft, Inc. (North Attleboro, MA) from 2006 to 2011: 3 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and LLZ (System, Image Processing, Radiological). 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 Diagnosoft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 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 — Diagnosoft, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • LLZSystem, Image Processing, 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 7 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.

  • K100352Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 20104cite it
  • K111833VirtueDiagnosoft, Inc. · 20112cite it
  • K061368Diagnosoft HarpDiagnosoft, Inc. · 20061cites it

What has FDA decided for it lately?

  • K111833VirtueDiagnosoft, Inc. · 2011
  • K100352Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
  • K061368Diagnosoft HarpDiagnosoft, Inc. · 2006

All 3 as Diagnosoft, Inc. →