FDA clears Hologic I-View mammography system

Hologic received FDA 510(k) clearance for its I-View mammography system. The device is classified under product code MUE (Full Field Digital Mammography).

• The I-View system is classified under product code MUE (Full Field Digital Mammography System).
• Clearance was obtained via the FDA 510(k) premarket notification pathway.
• Hologic, Inc. is the applicant.

Automated summary

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