Data / Medical devices / United States / GE Medical Systems Information Technologies, Inc.
GE Medical Systems Information Technologies, Inc.: FDA-registered device maker in Wauwatosa, WI, United States, 30 510(k) clearances
GE Medical Systems Information Technologies, Inc. is registered with the FDA (registration 3012359877) in Wauwatosa, WI, United States. It lists 40 device types. The FDA files 30 510(k) clearances under its listings, the newest dated July 24, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012359877
- Address
- 9900 Innovation Drive, Wauwatosa, WI, United States, 53226
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 11, 1995
- Registered through
- 2027
- Brand names listed
- 12 RL Algorithm, 12SL ECG Analysis Program, 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in., 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in., 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in., 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| January 26, 2026 | K251670 | MAC 7 Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 25, 2024 | K233810 | Portrait VSM | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 20, 2024 | K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| December 13, 2023 | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| December 20, 2022 | K221904 | EK12 V2 Algorithm | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| October 18, 2022 | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| June 23, 2022 | K220732 | Mural Perinatal Surveillance | HGM | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 12, 2022 | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 1, 2022 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| February 17, 2022 | K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX | DQK | Substantially Equivalent | Ge Healthcare Information Technologies, Inc. | accessdata.fda.gov |
| April 30, 2021 | K203786 | MAC 7 - Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 29, 2020 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES | MHX | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 18, 2018 | K173830 | MAC VU360 Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| September 15, 2016 | K162012 | CARESCAPE Central Station V2 | DXJ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 12, 2016 | K152993 | MUSE Cardiology Information System | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| February 5, 2015 | K141963 | 12SL ECG ANALYSIS PROGRAM | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| January 23, 2014 | K133622 | MAC 2000 ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | Wipro GE Healthcare | accessdata.fda.gov |
| May 1, 2013 | K130626 | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 9, 2013 | K123996 | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| October 3, 2012 | K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | DXQ | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| May 17, 2011 | K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 29, 2011 | K110266 | MAC 5500 HD, MAC 3500 | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| February 16, 2011 | K103678 | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies GmbH | accessdata.fda.gov |
| February 24, 2010 | K092369 | 12SL ECG ANALYSIS PROGRAM | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| July 29, 2009 | K091594 | HEART-EXERCISE | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies GmbH | accessdata.fda.gov |
| June 20, 2008 | K080251 | APEXPRO TELEMETRY SYSTEMS | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| May 11, 2007 | K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| August 4, 2006 | K060307 | 12 RL ALGORITHM | DRT | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 29, 2026 | 99400 | Class II | Ongoing | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient. | accessdata.fda.gov |
| April 24, 2026 | 98932 | Class II | Ongoing | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury. | accessdata.fda.gov |
| April 25, 2025 | 96830 | Class II | Ongoing | 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. | The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data. | accessdata.fda.gov |
| April 22, 2024 | 94717 | Class II | Ongoing | 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 part #5875569 (Assy | Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms. | accessdata.fda.gov |
| April 9, 2024 | 94597 | Class II | Ongoing | 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 - 25 CM, 20/BOX; 3. ONE- | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | accessdata.fda.gov |
| August 8, 2023 | 92903 | Class II | Ongoing | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Blood Pressure Cuff
Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.