Atlas FDA

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

Aurora Imaging Technology, Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time
288 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073425MODIFICATION TO AURORA MRI SYSTEMAurora Imaging Technology, Inc.2008-09-162880
K052698MODIFICATION TO: AURORAAurora Imaging Technology, Inc.2005-11-08410
K032678MODIFICATION TO: AURORAAurora Imaging Technology, Inc.2003-09-24260
K032082AURORAAurora Imaging Technology, Inc.2003-07-30230
K023686AURORA MR-GUIDED INTERVENTIONAL SYSTEMAurora Imaging Technology, Inc.2003-01-29890
K012154AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICEAurora Imaging Technology, Inc.2001-09-19700
K003651AURORAAurora Imaging Technology, Inc.2001-02-21860

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