510(k) K190646
K190646 is an FDA 510(k) premarket notification submitted by Qt Ultrasound, LLC for the device "QT Scanner 2000 Model A". The FDA issued a decision of Substantially Equivalent on Oct 18, 2019. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Qt Ultrasound, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 2019
- Date Received
- Mar 13, 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)