REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION— 510(k) K051523

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K051523 for REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION, Substantially Equivalent on 2005-07-20. Applicant: Konica Minolta Medical & Graphic, Inc..

Clearance details

Applicant: Konica Minolta Medical & Graphic, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-06-08
Decision date: 2005-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watarai-Gun, Mie-Ken, JP

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.