Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Resonance Health Analysis Services Pty, Ltd. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time
520 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.2023-06-20320
K213776LiverSmartResonance Health Analysis Services Pty, Ltd.2021-12-29270
K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.2020-12-072310
K182218FerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd.2018-11-301070
K122035HEPAFAT SCANResonance Health Analysis Services Pty, Ltd.2013-12-135200
DEN130012FERRISCAN R2-MRI ANALYSIS SYSTEMResonance Health Analysis Services Pty, Ltd.2013-01-23210
K111222MRI-Q SYSTEMResonance Health Analysis Services Pty, Ltd.2011-07-28870

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda