Class Class II
Flash Ultrasound System 5100 Point of Care (K250030)
Description
Flash Ultrasound System 5100 Point of Care by Philips Ultrasound, LLC, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250030
Clearance Date2025-04-28
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250030
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. Flash Ultrasound System 5100 Point of Care (K250030) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231190 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2023 |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5... | Philips Ultrasound, LLC | 2022 |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultraso... | Philips Health Care | 2016 |
Trace the full predicate network for K250030
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.