Clearance Summary
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM received FDA 510(k) clearance under submission number K110717, sponsored by Konica Minolta Medical & Graphic, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-12-23.
- Submission: K110717
- Applicant / Sponsor: Konica Minolta Medical & Graphic, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1715
- Decision date: 2011-12-23
Classification & Regulation
This clearance is catalogued under FDA product code MUE and 21 CFR 892.1715, within the Radiology review panel as a Class II device.