Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Philips Medical Systems Nethrlands BV — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

114 daysmedian FDA review time

144 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162148	Allura Xper R9	Philips Medical Systems Nethrlands BV	2016-11-23	114	2
K153022	Philips IntelliSpace Cardiovascular	Philips Medical Systems Nethrlands BV	2015-11-18	34	3
K150665	Philips Spectral CT Applications	Philips Medical Systems Nethrlands BV	2015-08-07	144	0
K143606	MultiBand SENSE	Philips Medical Systems Nethrlands BV	2015-05-08	140	0
K142708	VERADIUS UNITY	Philips Medical Systems Nethrlands BV	2014-10-22	30	2

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