510(k) K192170
K192170 is an FDA 510(k) premarket notification submitted by Emagine Solutions Technology, LLC for the device "VistaScan USB Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on Jan 23, 2020. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2020
- Date Received
- Aug 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)