510(k) K191663
K191663 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0". The FDA issued a decision of Substantially Equivalent on Sep 18, 2019. 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
- Sep 18, 2019
- Date Received
- Jun 21, 2019
- 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)