Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems Technologies , Ltd. · 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) |
|---|---|---|---|---|---|
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 | 127 | 0 |
| K244008 | Spectral CT | Philips Medical Systems Technologies , Ltd. | 2025-05-16 | 141 | 1 |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies , Ltd. | 2024-10-18 | 205 | 0 |
| K173588 | Illumeo System | Philips Medical Systems Technologies , Ltd. | 2018-01-12 | 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