K252074
- 510(k) number
- K252074
- Device name
- Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-10-31
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252074.pdf
Official FDA record: K252074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.