K252018
- 510(k) number
- K252018
- Device name
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-01-05
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252018.pdf
Official FDA record: K252018
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.