510(k) K143020
K143020 is an FDA 510(k) premarket notification submitted by Mirada Medical, Ltd. for the device "LiverMultiScan". The FDA issued a decision of Substantially Equivalent on Jun 23, 2015. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Mirada Medical, Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2015
- Date Received
- Oct 20, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)