Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems MR Finland — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020-01-24 | 77 | 0 |
| K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019-04-30 | 197 | 0 |
| K151435 | MRCAT | Philips Medical Systems MR Finland | 2016-02-25 | 273 | 0 |
| K080120 | HFO SHOULDER COIL | Philips Medical Systems MR Finland | 2008-03-10 | 53 | 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