Company · US
Ge Medical Systems Information Technologies
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2026. Name variants (Inc, Corp, punctuation) are merged.
171510(k) clearances (2 in 12 months)
29recalls (14 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 42 |
| HGM | System, Monitoring, Perinatal | 30 |
| DQK | Computer, Diagnostic, Programmable | 23 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 18 |
| DPS | Electrocardiograph | 10 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 |
| BZQ | Monitor, Breathing Frequency | 6 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 |
| DXQ | Blood Pressure Cuff | 5 |
| DSF | Recorder, Paper Chart | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 |
| HGL | Transducer, Ultrasonic, Obstetric | 3 |
| JOP | Transducer, Ultrasonic | 3 |
| LLZ | System, Image Processing, Radiological | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 |
| DQA | Oximeter | 2 |
| DXJ | Display, Cathode-Ray Tube, Medical | 2 |
| DXK | Echocardiograph | 2 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P Ge Medical Systems Information Technologies, Inc. | MHX |
| Jan 26, 2026 | K251670 | MAC 7 Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc. | DPS |
| Jul 9, 2025 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P Ge Medical Systems Information Technologies, Inc. | MHX |
| Dec 12, 2024 | K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) Ge Medical Systems Information Technologies, Inc. | DQK |
| Apr 25, 2024 | K233810 | Portrait VSM Ge Medical Systems Information Technologies, Inc. | MWI |
| Mar 20, 2024 | K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Ge Medical Systems Information Technologies, Inc. | MWI |
| Dec 13, 2023 | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System Ge Medical Systems Information Technologies, Inc. | DQK |
| Aug 11, 2023 | K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Al Ge Medical Systems Information Technologies, Inc. | MWI |
| Mar 14, 2023 | K230145 | ONE-CUF Ge Medical Systems Information Technologies, Inc. | DXQ |
| Dec 21, 2022 | K222586 | Mural Clinical Viewer Ge Medical Systems Information Technologies, Inc. | MHX |
| Dec 20, 2022 | K221904 | EK12 V2 Algorithm Ge Medical Systems Information Technologies, Inc. | MHX |
| Oct 18, 2022 | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc. | DPS |
| Jun 23, 2022 | K220732 | Mural Perinatal Surveillance Ge Medical Systems Information Technologies, Inc. | HGM |
| Apr 12, 2022 | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Ge Medical Systems Information Technologies, Inc. | MHX |
| Apr 1, 2022 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P Ge Medical Systems Information Technologies, Inc. | MHX |
| Apr 30, 2021 | K203786 | MAC 7 - Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc. | DPS |
| Dec 8, 2020 | K202189 | Graffiti Ge Medical Systems Information Technologies, Inc. | DQK |
| Nov 4, 2020 | K201941 | Monitor B125, Monitor B105 Ge Medical Systems Information Technologies, Inc. | MHX |
| Sep 18, 2018 | K173830 | MAC VU360 Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc. | DPS |
| Jun 6, 2017 | K170155 | EK12 Algorithm Ge Medical Systems Information Technologies, Inc. | MHX |
| Jan 12, 2016 | K152993 | MUSE Cardiology Information System Ge Medical Systems Information Technologies, Inc. | DQK |
| Feb 5, 2015 | K141963 | 12SL ECG ANALYSIS PROGRAM Ge Medical Systems Information Technologies, Inc. | MHX |
| Apr 30, 2014 | K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) Ge Medical Systems Information Technologies, Inc. | DXJ |
| Dec 4, 2013 | K132437 | MARS HOLTER ANALYSIS WORKSTATION Ge Medical Systems Information Technologies, Inc. | DQK |
| May 1, 2013 | K130626 | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS Ge Medical Systems Information Technologies, Inc. | DQK |
| Apr 9, 2013 | K123996 | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF Ge Medical Systems Information Technologies, Inc. | DXQ |
| Mar 1, 2013 | K130155 | MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Inc. | DQK |
| Dec 6, 2012 | K120770 | QT GUARD PLUS ANALYSIS SYSTEM Ge Medical Systems Information Technologies | DPS |
| Oct 3, 2012 | K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF Ge Medical Systems Information Technologies, Inc. | DXQ |
| May 25, 2011 | K110132 | MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Inc. | DQK |
| May 17, 2011 | K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies, Inc. | DPS |
| Apr 29, 2011 | K110266 | MAC 5500 HD, MAC 3500 Ge Medical Systems Information Technologies, Inc. | DPS |
| Feb 16, 2011 | K103678 | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM Ge Medical Systems Information Technologies GmbH, DE | DQK |
| Dec 17, 2010 | K103432 | UNITY NETWORK ID Ge Medical Systems Information Technologies, Inc. | MWI |
| Oct 20, 2010 | K102426 | CARESCAPE MODEL V100 VITAL SIGNS MONITOR Ge Medical Systems Information Technologies | MWI |
| Feb 24, 2010 | K092369 | 12SL ECG ANALYSIS PROGRAM Ge Medical Systems Information Technologies | MHX |
| Dec 29, 2009 | K093141 | MARS HOLTER ANALYSIS WORKSTATION Ge Medical Systems Information Technologies | DQK |
| Aug 28, 2009 | K092027 | CARESCAPE MONITOR B850 Ge Medical Systems Information Technologies | MHX |
| Jul 29, 2009 | K091594 | HEART-EXERCISE Ge Medical Systems Information Technologies GmbH | MHX |
| Apr 15, 2009 | K090702 | MODIFICATION TO DASH 2500 PATIENT MONITOR Ge Medical Systems Information Technologies | MHX |
| Mar 23, 2009 | K083750 | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM Ge Medical Systems Information Technologies | MHX |
| Feb 17, 2009 | K083639 | MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE Ge Medical Systems Information Technologies | DQK |
| Nov 19, 2008 | K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM Ge Medical Systems Information Technologies | DSA |
| Jul 15, 2008 | K081437 | MAC 1600 ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies | DPS |
| Jun 20, 2008 | K080251 | APEXPRO TELEMETRY SYSTEMS Ge Medical Systems Information Technologies | MHX |
| Mar 24, 2008 | K080157 | DASH 2500 PATIENT MONITOR Ge Medical Systems Information Technologies | MHX |
| Jan 11, 2008 | K073462 | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES Ge Medical Systems Information Technologies | MHX |
| Nov 29, 2007 | K073203 | CARESCAPE V100 Ge Medical Systems Information Technologies | MHX |
| Nov 19, 2007 | K072502 | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies | DQK |
| Sep 21, 2007 | K071982 | MODIFICATION TO: UNITY NETWORK ID Ge Medical Systems Information Technologies | MWI |
Newest 50 of 171.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | GE Medical Systems Information Technologies Inc Carescape Central Station
CSCS V3 MAS800 Desktop
Part Number 5867474-04, 5867474-13
Product code STU
CSCS V3 MAI800 Integrated
Part Number 5867474-03
Product Code STV Open, Classified |
DQK | K162012 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 Open, Classified |
MWI | None listed |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Open, Classified |
MWI | K230626 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Open, Classified |
MWI | K234130 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Open, Classified |
MWI | K234130 |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 Open, Classified |
MWI | K234130 |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph Open, Classified |
DPS | K173830 |
| Jun 1, 2026 | GE Medical Systems Information Technologies Inc CASE v7.0 Cardiac Testing System
Model no. 3031234-001
Product Code SU3 Open, Classified |
DQK | K231870 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia D Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physio Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Pati Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patien Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Open, Classified |
MHX | K080251 |
| Jun 10, 2025 | GE Medical Systems Information Technologies Inc MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. Open, Classified |
DSI | K992637 |
| Jul 3, 2024 | GE Medical Systems Information Technologies Inc Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare Open, Classified |
DQK | K050093 |
| Jun 6, 2024 | GE Medical Systems Information Technologies Inc GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers:
1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX;
2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - Open, Classified |
DXQ | K230145 |
| Sep 19, 2023 | GE Medical Systems Information Technologies Inc Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. Open, Classified |
DQK | K213972 |
| Jan 25, 2018 | GE Medical Systems Information Technologies, Inc. GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2
The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physio Terminated |
DQK | K162012 |
| Jul 13, 2017 | GE Medical Systems Information Technologies, Inc. CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software
The PDM is intended to provide uninterrupted acquisition of physiologic p Terminated |
MHX | K071073 |
| Aug 30, 2005 | GE Medical Systems Information Technologies GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05 Terminated |
LLZ | K955519 |
| Jul 20, 2004 | GE Medical Systems Information Technologies Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEX Terminated |
MHX | None listed |
| Oct 15, 2003 | GE Medical Systems Information Technologies Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Me Terminated |
MWI | K012915 K020022 +1 |
| Oct 15, 2003 | GE Medical Systems Information Technologies Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs Terminated |
None listed | |
| Oct 15, 2003 | GE Medical Systems Information Technologies Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136 Terminated |
None listed | |
| Oct 15, 2003 | GE Medical Systems Information Technologies Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130 Terminated |
None listed | |
| Oct 15, 2003 | GE Medical Systems Information Technologies Critikon brand Omni-Stat Finger Sensor - P/N 009084 Terminated |
K925542 | |
| Sep 23, 2003 | GE Medical Systems Information Technologies GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is Terminated |
HGM | K021135 |
| Sep 17, 2003 | GE Medical Systems Information Technologies Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor. Terminated |
K974080 |