K241971
- 510(k) number
- K241971
- Device name
- HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-10-11
- Date received
- 2024-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K241971.pdf
Official FDA record: K241971
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.