EXA— 510(k) K203743

Substantially Equivalent

Konica Minolta Healthcare Americas, Inc.

FDA 510(k) clearance K203743 for EXA, Substantially Equivalent on 2021-12-10. Applicant: Konica Minolta Healthcare Americas, Inc..

Clearance details

Applicant: Konica Minolta Healthcare Americas, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-12-22
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Garner, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.