K233788
- 510(k) number
- K233788
- 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
- 2024-02-13
- Date received
- 2023-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233788.pdf
Official FDA record: K233788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.