Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Fujifilm Healthcare Corporation · Predicate Candidate Screening

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

166 daysmedian FDA review time
241 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation2024-08-13840
K240571OASIS MRI SystemFujifilm Healthcare Corporation2024-04-12430
K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation2023-07-132410
K221619ECHELON Oval V6.2 MRI SystemFujifilm Healthcare Corporation2023-01-262370
K213829SCENARIA ViewFujifilm Healthcare Corporation2022-05-231660
K220295ARIETTA 50Fujifilm Healthcare Corporation2022-04-29860

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