Class Class II
EPIQ Series Diagnostic Ultrasound System (K231190)
Description
EPIQ Series Diagnostic Ultrasound System by Philips Ultrasound, LLC, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231190
Clearance Date2023-05-12
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231190
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. EPIQ Series Diagnostic Ultrasound System (K231190) cites 2 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti... | Philips Medical Systems | 2021 |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultraso... | Philips Health Care | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250030 | Flash Ultrasound System 5100 Point of Care | Philips Ultrasound, LLC | 2025 |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series D... | Philips Ultrasound, LLC | 2024 |
| K233545 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2023 |
Trace the full predicate network for K231190
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.