510(k) K242808
K242808 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5". The FDA issued a decision of Substantially Equivalent on May 13, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Canon Medical Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2025
- Date Received
- September 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type