RSI-MRI+— 510(k) K191278
Substantially EquivalentMultimodal Imaging Services Corporation (Dba Healthlytix)
FDA 510(k) clearance K191278 for RSI-MRI+, Substantially Equivalent on 2019-11-19. Applicant: Multimodal Imaging Services Corporation (Dba Healthlytix).
Clearance details
- Applicant
- Multimodal Imaging Services Corporation (Dba Healthlytix)
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.