510(k) K212333
K212333 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5". The FDA issued a decision of Substantially Equivalent on Jan 24, 2022. 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 96 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2022
- Date Received
- Jul 27, 2021
- 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
- 510(k)