Devices

Device Recall Regius

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Regius
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    These units have been distributed to hospitals and clinics nationwide.
  • 제품 설명
    Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
  • Manufacturer
    Konica Medical Imaging, Inc.
Device Recall REGIUS IM, RIM
  • 모델명 / 제조번호(시리얼번호)
    58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
  • 제품 설명
    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
    Konica Minolta Medical Imaging USA, Inc.