K242808
- 510(k) number
- K242808
- Device name
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-05-13
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242808.pdf
Official FDA record: K242808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.