KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM— 510(k) K110717

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K110717 for KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2011-12-23. Applicant: Konica Minolta Medical & Graphic, Inc..

Clearance details

Applicant: Konica Minolta Medical & Graphic, Inc.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2011-03-15
Decision date: 2011-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

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Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.