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510(k) K133882

CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) by Ge Medical Systems Information Technologies, Inc. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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  • K230626 — Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (August 11, 2023)
  • K230145 — ONE-CUF (March 14, 2023)
  • K222586 — Mural Clinical Viewer (December 21, 2022)
  • K221904 — EK12 V2 Algorithm (December 20, 2022)

Other clearances for product code DXJ

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  • K201162 — Essence 55SP Large Monitor System (August 27, 2020)
  • K173107 — Vios Central Station Monitor Software, Vios Central Server Software (July 26, 2018)
  • K180534 — Philips IntelliVue GuardianSoftware (July 16, 2018)
  • K173381 — Nexxis OR (February 22, 2018)
  • K172969 — Essence 55S Large Monitor System (January 26, 2018)
  • K170460 — Sorin Connect (June 8, 2017)
  • K170537 — Nexxis OR, Nexxis (April 21, 2017)
  • K161880 — NIVR58-T kit (March 14, 2017)