Autoplaque— 510(k) K212758
Substantially EquivalentCedars-Sinai Medical Center: Aim
FDA 510(k) clearance K212758 for Autoplaque, Substantially Equivalent on 2023-05-19. Applicant: Cedars-Sinai Medical Center: Aim.
Clearance details
- Applicant
- Cedars-Sinai Medical Center: Aim
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, 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.