MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION— 510(k) K053356

Clearance details

Applicant

Ge Medical Systems Information Technologies

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2005-12-02

Decision date

2006-04-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milwaukee, WI, US

• K212003 — ESSENZ Patient Monitor2021-11-10
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• K201162 — Essence 55SP Large Monitor System2020-08-27
• K173107 — Vios Central Station Monitor Software, Vios Central Server Software2018-07-26
• K180534 — Philips IntelliVue GuardianSoftware2018-07-16

• K120770 — QT GUARD PLUS ANALYSIS SYSTEM2012-12-06
• K102426 — CARESCAPE MODEL V100 VITAL SIGNS MONITOR2010-10-20
• K092369 — 12SL ECG ANALYSIS PROGRAM2010-02-24
• K093141 — MARS HOLTER ANALYSIS WORKSTATION2009-12-29
• K092027 — CARESCAPE MONITOR B8502009-08-28

Death

2

Total

2

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 →

• Z-0726-2020 — CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.Class II·Terminated·GE Healthcare, LLC·20191112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053356.