510(k) K231459
K231459 is an FDA 510(k) premarket notification submitted by Resonance Health Analysis Services Pty, Ltd. for the device "HepaFatSmart (V2.0.0)". The FDA issued a decision of Substantially Equivalent on June 20, 2023. 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 at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2023
- Date Received
- May 19, 2023
- Clearance Type
- Special
- 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