K241582
- 510(k) number
- K241582
- Device name
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-09-12
- Date received
- 2024-06-03
- 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: K241582.pdf
Official FDA record: K241582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.