Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Resonance Health Analysis Services with 6 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 20, 2023: HepaFatSmart (V2.0.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 20, 2023 | HepaFatSmart (V2.0.0)K231459 · LNH | 510(k) clearances |
| Jun 20, 2023 | HepaFatSmart (V2.0.0)K231459 · Radiology | AI-enabled devices |
| Dec 29, 2021 | LiverSmartK213776 · PCS | 510(k) clearances |
| Dec 29, 2021 | LiverSmartK213776 · Radiology | AI-enabled devices |
| Dec 7, 2020 | HepaFat-AIK201039 · LNH | 510(k) clearances |
| Dec 7, 2020 | HepaFat-AIK201039 · Radiology | AI-enabled devices |
| Nov 30, 2018 | FerriSmart Analysis SystemK182218 · PCS | 510(k) clearances |
| Nov 30, 2018 | FerriSmart Analysis SystemK182218 · Radiology | AI-enabled devices |
| Dec 13, 2013 | HEPAFAT SCANK122035 · LNH | 510(k) clearances |
| Jan 23, 2013 | FERRISCAN R2-MRI ANALYSIS SYSTEMDEN130012 · PCS | 510(k) clearances |
| Jul 28, 2011 | MRI-Q SYSTEMK111222 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
