FDA clears Sectras full-field digital mammo system

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Screening mammography with breast tomosynthesis in a 57-year-old woman. Image source: RadioGraphics

The FDA has granted approval for the 510(k) application by Sectra Medical Systems to sell the Sectra MicroDose L30 full-field digital mammography (FFDM) unit in the U.S.

The Linköping, Sweden-based company said its Sectra MicroDose Mammography L30 is a flat-panel FFDM system with scanning multislit geometry and a 24 x 26-cm field-of-view, as well as photon-counting technology.

Until accreditation is available from their accreditation bodies, mammography facilities that want to use this unit under their existing Mammography Quality Standards Act (MQSA) certificate must apply to the FDA’s Certification Extension Program.