510(k) K201039
K201039 is an FDA 510(k) premarket notification submitted by Resonance Health Analysis Services Pty, Ltd. for the device "HepaFat-AI". The FDA issued a decision of Substantially Equivalent on Dec 7, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Resonance Health Analysis Services Pty, Ltd. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 2020
- Date Received
- Apr 20, 2020
- 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)