Device Recall Regius

Manufacturer

  • Manufacturer Address
    Konica Minolta Medical Imaging USA, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    These units have been distributed to hospitals and clinics nationwide.
  • Product Description
    Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
  • Manufacturer
  • Model / Serial
    58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
  • Product Description
    REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
  • Manufacturer