510(k) K180100
K180100 is an FDA 510(k) premarket notification submitted by Mriaudio for the device "MRIaudio PREM System". The FDA issued a decision of Substantially Equivalent on Jun 14, 2018. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Mriaudio has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2018
- Date Received
- Jan 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)