HepaFat-AI— 510(k) K201039
Substantially EquivalentResonance Health Analysis Services Pty, Ltd.
FDA 510(k) clearance K201039 for HepaFat-AI, Substantially Equivalent on 2020-12-07. Applicant: Resonance Health Analysis Services Pty, Ltd..
Clearance details
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Perth, AU
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.