# Ge Medical Systems Information Technologies

- Location (FDA's records): Wallingford, CT
- FDA decisions: 172 (1978–2026): 171 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Ge Medical Systems Information Technologies (137); Ge Medical Systems Information Technologies, Inc. (32); Ge Medical Systems Information Technologies GmbH (3)
- Product codes: MHX (34), HGM (29), DQK (18), MWI (12), DPS (9), IYO (7), DRT (6), BZQ (6), ITX (6), DXQ (4), JOP (3), HGL (3)
- 510(k) review time since 2016: median 149 days, against 190 for FDA's reviews in the same codes and years (13 of 20 faster)
- Predicates its devices cite: 162 (71 its own); citations of its devices by later devices: 177 (71 its own)
- Recalls linked to its devices: 124 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- General Electric Medical Systems Information Techn: 23 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Nellcor Puritan Bennett, Inc.: 6 (https://510kreport.com/company/nellcor-puritan-bennett)
- Masimo Corporation: 6 (https://510kreport.com/company/masimo)
- Marquette Electronics, Inc.: 5 (https://510kreport.com/company/marquette-electronics)
- Marquette Medical Systems, Inc.: 5 (https://510kreport.com/company/marquette-medical-systems)
- GE Healthcare: 5 (https://510kreport.com/company/ge-healthcare)
- Critikon Company, LLC: 4 (https://510kreport.com/company/critikon)
- GE Healthcare Finland Oy: 4 (https://510kreport.com/company/ge-healthcare-finland)

## Firms that cite its devices most
- GE Healthcare: 8 (https://510kreport.com/company/ge-healthcare)
- GE Healthcare Finland Oy: 6 (https://510kreport.com/company/ge-healthcare-finland)
- General Electric Medical Systems Information Techn: 5 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Epic Medical Equipment Services, Inc.: 4 (https://510kreport.com/company/epic-medical-equipment-services)
- Ge Medical Systems China Co., Ltd.: 3 (https://510kreport.com/company/ge-medical-systems-china)
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Edan Instruments, Inc.: 3 (https://510kreport.com/company/edan-instruments)
- Getemed Medizin- Und Informationstechnik AG: 2 (https://510kreport.com/company/getemed-medizin-und-informationstechnik)

## Its most-cited devices
- K043415: Centricity Pacs System (2005), cited by 11
- K022482: Sensa-Cuff, Models Infant, Child, Adult (2002), cited by 6
- K031561: Cardiosoft/Case Cardiac Testing System (2003), cited by 6
- K071073: Solar 8000 and Transport Pro with Patient Data Module (2007), cited by 5
- K852608: Spectra 400 Extended Surveillance & Alert System (1985), cited by 4
- K900805: Aloka 500 Diagnostic Ultrasound Scanning System (1990), cited by 4

## Recent decisions
- K253277: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (Jul 24, 2026)
- K251670: MAC 7 Resting ECG Analysis System (Jan 26, 2026)
- K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (Jul 9, 2025)
- K243540: Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (Dec 12, 2024)
- K233810: Portrait VSM (Apr 25, 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 (Mar 20, 2024)
- K231870: CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (Dec 13, 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™ (Aug 11, 2023)

Source page: https://510kreport.com/company/ge-medical-systems-information-technologies