Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mckesson Medical Imaging Company · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142850 | McKesson Radiology Mammography Plus | Mckesson Medical Imaging Company | 2015-01-06 | 98 | 0 |
| K140909 | MCKESSON RADIOLOGY | Mckesson Medical Imaging Company | 2014-07-02 | 84 | 2 |
| K043146 | HORIZON MEDICAL IMAGING | Mckesson Medical Imaging Company | 2005-01-04 | 50 | 10 |
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