K232988
- 510(k) number
- K232988
- Device name
- Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-11-21
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232988.pdf
Official FDA record: K232988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.