K253597
- 510(k) number
- K253597
- Device name
- Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-01-20
- Date received
- 2025-11-18
- 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: K253597.pdf
Official FDA record: K253597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.