CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)— 510(k) K133882

Clearance details

Applicant

Ge Medical Systems Information Technologies, Inc.

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2013-12-20

Decision date

2014-04-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milwaukee, WI, US

• K212003 — ESSENZ Patient Monitor2021-11-10
• K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)2021-09-30
• 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

• K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24
• K251670 — MAC 7 Resting ECG Analysis System2026-01-26
• K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2025-07-09
• K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)2024-12-12
• K233810 — Portrait VSM2024-04-25

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-0727-2020 — CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE 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 K133882.