MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER— 510(k) K062976

Name: FDA 510(k) clearance K062976
Creator: U.S. Food and Drug Administration
Published: 2007-03-16

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K062976 for MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER, Substantially Equivalent on 2007-03-16. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2007-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

view all

K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)2026-01-23
K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

More clearances from Ge Medical Systems Information Technologies

view all

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

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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 →

Recalls naming K062976

K-number listed on FDA's recall record

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 K062976.

Data sourced from openFDA. This site is unofficial and independent of the FDA.