K242444
- 510(k) number
- K242444
- Device name
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-11-27
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242444.pdf
Official FDA record: K242444
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.