K242511
- 510(k) number
- K242511
- Device name
- V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-12-10
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242511.pdf
Official FDA record: K242511
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.