Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Image Guided Therapy Corporation — 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) |
|---|---|---|---|---|---|
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 | 92 | 0 |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); | Philips Image Guided Therapy Corporation | 2025-05-09 | 28 | 0 |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, Veri | Philips Image Guided Therapy Corporation | 2020-09-02 | 159 | 0 |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | 2020-05-22 | 93 | 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