510(k) K202364
K202364 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1". The FDA issued a decision of Substantially Equivalent on Oct 15, 2020. 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
- Oct 15, 2020
- Date Received
- Aug 19, 2020
- 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)