K250999
- 510(k) number
- K250999
- Device name
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-07-18
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250999.pdf
Official FDA record: K250999
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.