510(k) K233195
K233195 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on January 24, 2024. 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
- January 24, 2024
- Date Received
- September 28, 2023
- 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