Class Class II
Lumify Diagnostic Ultrasound System (K242519)
Description
Lumify Diagnostic Ultrasound System by Philips Ultrasound, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242519
Clearance Date2025-05-15
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242519
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Lumify Diagnostic Ultrasound System (K242519) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series ... | Philips Ultrasound, LLC | 2024 |
| K203406 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2021 |
| K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019 |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Health Care | 2012 |
Trace the full predicate network for K242519
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.