Public change record

What changed—and why.

Substantive regulatory, evidence, safety, and method changes are logged here. Copy edits that do not alter meaning may be omitted.

Aug 24, 2026v0.3

Independent re-audit and methods release

  • Updated Acorn 3D to latest family record K260322 and retained K252103 as predecessor evidence.
  • Separated current UNiD v5.1 evidence from the 1,050-case validation reported for predecessor v5.0.
  • Corrected SpineAR sacral metric labels to match the FDA table.
  • Changed ScanDiags literature matching to Partial because the evaluated commercial version was not reported.
  • Updated xvision to latest record K261854 and added CoLumbo C-Spine to the AI-ambiguity watchlist.
  • Added CoLumbo and BoneMRI evidence, explicit trial statuses, source-specific version caveats, and smaller wording corrections.
  • Published the full search, matching, staging, independence, safety, and corrections methods.

No evidence-stage changes were made in this release.

Aug 2026v0.2

Public beta

Expanded the spine index to 17 curated platform families, added a vertical evidence-stage ladder, a verification watchlist, source links, an editor page, and the clearancetoclinic.com domain.

Aug 2026v0.1

Initial prototype

Established the clearance-to-evidence concept, spine-first scope, and initial FDA-to-clinical-evidence device cards.

Corrections

Found something that needs another look?

Include the device, statement at issue, and the strongest primary source you have. Correction requests do not guarantee a change, but every specific, source-backed request will be reviewed.

corrections@clearancetoclinic.com →