Mammomat Revelation— 510(k) K173408
Substantially EquivalentSiemens Medi Cal Solutions, Inc.
FDA 510(k) clearance K173408 for Mammomat Revelation, Substantially Equivalent on 2018-03-21. Applicant: Siemens Medi Cal Solutions, Inc..
Clearance details
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Product code
- Code MUE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Adverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
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.