Atlas FDA

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

Philips Ultrasound, LLC · Predicate Candidate Screening

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

86 daysmedian FDA review time
180 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-08-04270
K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips AfPhilips Ultrasound, LLC2026-07-271040
K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-06-291190
K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-05-271320
K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series DPhilips Ultrasound, LLC2026-05-27860
K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-05-052650
K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series DiPhilips Ultrasound, LLC2026-03-271290
K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2025-12-221310
K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2025-10-091330
K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2025-07-24730
K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series DPhilips Ultrasound, LLC2025-06-18850
K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2025-05-211620
K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series DPhilips Ultrasound, LLC2025-05-09280
K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC2025-04-281125
K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2025-04-10780
K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC2025-02-102450
K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2025-02-06580
K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series DiPhilips Ultrasound, LLC2024-12-121540
K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC2024-11-15590
K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024-10-071800
K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series DPhilips Ultrasound, LLC2024-04-24280
K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series DiPhilips Ultrasound, LLC2024-02-13771
K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2023-11-30271
K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2023-05-12164
K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC2023-01-18300
K2226485000 Compact Series Ultrasound Systems (Ultrasound System 55Philips Ultrasound, LLC2022-09-27262

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