SECTRA MICRODOSE MAMMOGRAPHY— 510(k) K110025
Substantially EquivalentSectra Imtec AB
FDA 510(k) clearance K110025 for SECTRA MICRODOSE MAMMOGRAPHY, Substantially Equivalent on 2011-04-28. Applicant: Sectra Imtec AB. Device class: 2.
Clearance details
- Applicant
- Sectra Imtec AB
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Linkoping, SE
Recent devices under product code MUE
view allMore clearances from Sectra Imtec AB
view allAdverse 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.