510(k) K162972
K162972 is an FDA 510(k) premarket notification submitted by Exact Imaging for the device "ExactVu High Resolution Micro-Ultrasound System". The FDA issued a decision of Substantially Equivalent on Dec 2, 2016. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Exact Imaging has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2016
- Date Received
- Oct 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)