K260680
- 510(k) number
- K260680
- Device name
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- Applicant
- Philips Ultrasound, LLC WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-05-27
- Date received
- 2026-03-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260680.pdf
Official FDA record: K260680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.