FDA 510 (k) clearance for Helianthus Digital Mammography System
We are happy to announce that on December 15, 2021, Metaltronica SpA has received 510(k) clearance from the U.S. Food and Drug Administration for its Helianthus Full-Field Digital Mammography system.
The clearance documents can be found here:
- https://fda.report/PMN/K202822
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202822
- https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202822.pdf
In addition, the mammography unit was recently exhibited in one of our shareholders’ booth (Medical Scientific) at the RSNA Congress in Chicago. It was a privilege to participate in the world’s most prestigious annual radiology event and introduce our proven diagnostic imaging solutions to U.S. mammography practitioners.
