K231941
- 510(k) number
- K231941
- Device name
- ARIETTA x10
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-11-20
- Date received
- 2023-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K231941.pdf
Official FDA record: K231941
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.