K233195
- 510(k) number
- K233195
- Device name
- Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-01-24
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233195.pdf
Official FDA record: K233195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.