K243793
- 510(k) number
- K243793
- Device name
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, LLC WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-05-21
- Date received
- 2024-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243793.pdf
Official FDA record: K243793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.