Device Recall Cardio Review Station (CRS)

  • 모델명 / 제조번호(시리얼번호)
    Software versions - 2.01.B10, 2.01.B15, 2.01.B25, 2.02.B32, 2.02.B39 2.02.B40, 2.02.B43, 2.03.B16, 2.02.B23, 2.03.B26, 2.03B31.P01, 2.03.B31, 2.04.B03, 2.04.B06, 2.05.B01, 2.04.B07, 2.06.47, 2.06.47.02, 2.05.B02, 2.06.47.08, 2.06.47.08, 2.06.47.08.03, 2.06.47.02, 2.06.47.18, 2.06.47.18.01, 2.06.47.27, 2.06.47.18.02, 2.06.47.30, 2.06.47.37, 2.06.47.40, 2.07.24, 2.08.05.01, 2.07.30.01, 2.07.30.02, 2.05.03.04, 2.09.03, 2.07.30.07, 2.07.35, 2.07.24.SLEH.07, 2.09.04.02, 2.07.35.01, 2.10.06, 2.11.06, 2.05.04.05, 2.12.09, 2.13.08, 2.13.08.SU1, 2.14.03, 2.14.03.SU1, 2.15.08, 2.14.03.SU2, 2.15.08.SU3, 2.16.08, 7.4.SU3, 7.8, 7.8.SU1, and 7.8.SU2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and country of Canada.
  • 제품 설명
    IMPAX CV (Cardio Vascular) || The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA