510(k) K190995
K190995 is an FDA 510(k) premarket notification submitted by Exact Imaging, Inc. for the device "ExactVu High Resolution Micro-Ultrasound System". The FDA issued a decision of Substantially Equivalent on May 10, 2019. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Exact Imaging, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2019
- Date Received
- Apr 16, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type
- 510(k)