Data / Medical devices / United States / GE Medical Systems Information Technologies, Inc.
GE Medical Systems Information Technologies, Inc.: FDA-registered device maker in Waukesha, WI, United States, 27 510(k) clearances
GE Medical Systems Information Technologies, Inc. is registered with the FDA (registration 3001570235) in Waukesha, WI, United States. It lists 40 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 24, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3001570235
- Address
- 3114 N Grandview Blvd, Waukesha, WI, United States, 53188
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- July 11, 1995
- Registered through
- 2027
- Brand names listed
- 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., 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 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 |
| December 12, 2024 | K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | DQK | 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 |
| December 21, 2022 | K222586 | Mural Clinical Viewer | MHX | 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 |
| 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 |
| 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 |
| September 26, 2011 | K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE | HGM | Substantially Equivalent | Ge Healthcare Integrated IT Solutions | accessdata.fda.gov |
| April 29, 2011 | K110266 | MAC 5500 HD, MAC 3500 | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| October 20, 2010 | K102426 | CARESCAPE MODEL V100 VITAL SIGNS MONITOR | MWI | 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 |
| November 29, 2007 | K073203 | CARESCAPE V100 | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 30, 2026 | 99637 | Class II | Ongoing | 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 | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. | accessdata.fda.gov |
| July 20, 2026 | 99536 | Class II | Ongoing | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. | accessdata.fda.gov |
| July 10, 2026 | 99475 | Class II | Ongoing | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system | A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI). | accessdata.fda.gov |
| April 24, 2026 | 98938 | Class II | Ongoing | 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 Arrhythmia Detection | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | accessdata.fda.gov |
Compare with other makers
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- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated September 11, 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.