Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Healthcare Americas · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
165 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021-10-07 | 154 | 0 |
| K202422 | Arietta 65 | Hitachi Healthcare Americas | 2020-11-04 | 72 | 0 |
| K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020-10-21 | 91 | 0 |
| K200498 | SCENARIA View | Hitachi Healthcare Americas | 2020-07-17 | 140 | 0 |
| K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020-02-21 | 141 | 0 |
| K190841 | SCENARIA View | Hitachi Healthcare Americas | 2019-09-13 | 165 | 0 |
| K191233 | ARIETTA 750 | Hitachi Healthcare Americas | 2019-08-09 | 93 | 0 |
| K190248 | ARIETTA 50 | Hitachi Healthcare Americas | 2019-04-02 | 54 | 0 |
| K183291 | Supria True64 Whole-Body X-Ray CT System | Hitachi Healthcare Americas | 2019-02-01 | 67 | 0 |
| K183456 | Aloka Arietta 850 | Hitachi Healthcare Americas | 2019-01-28 | 46 | 0 |
| K172492 | Optical Topography System ETG-4100 | Hitachi Healthcare Americas | 2018-08-17 | 365 | 0 |
| K180901 | Low Dose CT Lung Cancer Screening Option | Hitachi Healthcare Americas | 2018-05-16 | 40 | 0 |
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