510(k) Report

FDA applicant

Mindways Software, Inc.

San Francisco, CA3 decisions2001–20140 recalls

FDA records 3 decisions for Mindways Software, Inc. (San Francisco, CA) from 2001 to 2014: 3 510(k) clearances. All are in product code KGI (Densitometer, Bone). Its devices cite 7 predicates, 3 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 Mindways Software, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mindways Software, 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?

  • KGIDensitometer, Bone3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K002113Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 20015cite it
  • K030330Ctxa Hip Extended Reference DataMindways Software, Inc. · 20031cites it

What has FDA decided for it lately?

  • K140342QCT Pro Asynchronous Calibration Module, CliniqctMindways Software, Inc. · 2014
  • K030330Ctxa Hip Extended Reference DataMindways Software, Inc. · 2003
  • K002113Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001

All 3 as Mindways Software, Inc. →