510(k) K153626
K153626 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "SonoSite Edge II Ultrasound System". The FDA issued a decision of Substantially Equivalent on Jan 20, 2016. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. FUJIFILM Sonosite, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 20, 2016
- Date Received
- Dec 18, 2015
- Clearance Type
- Traditional
- 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