Atlas FDA

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

Resonance Innovations, LLC — Predicate Candidate Screening

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

32 daysmedian FDA review time
87 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142676Siemens 3.0T PROCURE Array CoilResonance Innovations, LLC2014-12-05770
K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC2014-10-23280
K1406061.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COILResonance Innovations, LLC2014-05-12630
K140282ST SENSE NV 8 ARRAY COILResonance Innovations, LLC2014-02-26220
K1339861.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAYResonance Innovations, LLC2014-01-27320
K1304573T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COILResonance Innovations, LLC2013-05-20870
K0611703.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000Resonance Innovations, LLC2006-05-25280
K0606891.5T PEDIATRIC HEAD AND SPINE ARRAY MODELResonance Innovations, LLC2006-03-31160

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