Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aspect Imaging, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
337 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 | 73 | 0 |
| K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017-07-19 | 107 | 0 |
| K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016-03-01 | 34 | 0 |
| K130692 | M2 WRIST 2 MRI SYSTEM | Aspect Imaging, Ltd. | 2014-01-14 | 307 | 0 |
| K120701 | M2 WRIST MRI SYSTEM | Aspect Imaging, Ltd. | 2013-02-07 | 337 | 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