# GE Medical Systems Ultrasound and Primary Care Diagnostics

- Location (FDA's records): Wauwatosa, WI
- FDA decisions: 70 (2015–2026): 70 510(k) clearances
- Names in FDA's records: GE Medical Systems Ultrasound and Primary Care Diagnostics (68); GE Medical Systems Ultrasound and Primary care Diagnostics, LLC (2)
- Product codes: IYN (62), LLZ (4), QIH (3), ITX (1)
- 510(k) review time since 2016: median 99 days, against 107 for FDA's reviews in the same codes and years (39 of 67 faster)
- Predicates its devices cite: 123 (60 its own); citations of its devices by later devices: 95 (60 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Healthcare: 25 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 7 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)
- GE Medical Systems: 5 (https://510kreport.com/company/ge-medical-systems)
- Ge Medical Systems Ultrasound And: 5 (https://510kreport.com/company/ge-medical-systems-ultrasound)
- Ge Medical Systems Ultrasound and Primary Care Diagnostic,: 4 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostic)
- Ge Medical Systems Ultrasound and Primary Care Diagnostics L: 4 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics-l)
- Ge Vingmed Ultrasound AS: 3 (https://510kreport.com/company/ge-vingmed-ultrasound)
- Ge Medical Systems Ultrasound and Primary Care Diagnotics, L: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnotics-l)

## Firms that cite its devices most
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 7 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)
- Ge Medical Systems Ultrasound And: 4 (https://510kreport.com/company/ge-medical-systems-ultrasound)
- GE Healthcare: 4 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Shenzhen Wisonic Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-wisonic-medical-technology)
- Vinno Technology (Suzhou) Co.,Ltd: 2 (https://510kreport.com/company/vinno-technology-suzhou)
- Wuhan United Imaging Healthcare Co.,Ltd: 2 (https://510kreport.com/company/wuhan-united-imaging-healthcare)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)

## Its most-cited devices
- K151028: LOGIQ e (2015), cited by 12
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2016), cited by 5
- K180599: Venue (2018), cited by 5
- K231966: Logiq E10 (2023), cited by 5
- K183362: Venue GO (2019), cited by 4
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), cited by 4

## Recent decisions
- K261933: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (Oct 2, 2026)
- K261623: EchoPAC Software Only / EchoPAC Plug-in (v211) (Sep 16, 2026)
- K261313: Vivid Explorer/Vivid Advanced/Vivid Focus (Sep 2, 2026)
- K261668: Venue Go (Aug 7, 2026)
- K261835: LOGIQ Focus (Jul 30, 2026)
- K260398: LOGIQ e (May 26, 2026)
- K260673: LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power (Mar 24, 2026)
- K253370: LOGIQ Totus (Jan 8, 2026)

Source page: https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics