# GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

- Location (FDA's records): Wauwatosa, WI
- FDA decisions: 15 (2016–2026): 15 510(k) clearances
- Product codes: IYN (8), KGI (4), LLZ (1), POK (1), QJU (1)
- 510(k) review time since 2016: median 89 days, against 83 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 34 (3 its own); citations of its devices by later devices: 16 (3 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 7 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- GE Healthcare: 5 (https://510kreport.com/company/ge-healthcare)
- Ge Medical Systems Israel: 2 (https://510kreport.com/company/ge-medical-systems-israel)
- Ge Medical Systems Ultrasound and Primary Care Diagnostics L: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics-l)
- Ge Medical Systems Ultrasound And: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound)
- Ge Medical Systems Lunar: 2 (https://510kreport.com/company/ge-medical-systems-lunar)
- Ge Medical Systems Ultrasound and Primary Care Dia: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-dia)
- Medimaps Group SA: 1 (https://510kreport.com/company/medimaps-group)

## Firms that cite its devices most
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 7 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Butterfly Network, Inc.: 1 (https://510kreport.com/company/butterfly-network)
- Jiangsu Tingsn Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-tingsn-technology)
- Rivanna Medical, Inc.: 1 (https://510kreport.com/company/rivanna-medical)
- 3D-Shaper Medical S.L: 1 (https://510kreport.com/company/3d-shaper-medical-s-l)

## Its most-cited devices
- K161588: Vscan Extend (2016), cited by 3
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), cited by 2
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), cited by 2
- K170714: Venue (2017), cited by 2
- K221148: Vivid iq (2022), cited by 2
- K170878: Vivid S60N, Vivid S70N (2017), cited by 1

## Recent decisions
- K261042: Lung Guidance (Oct 2, 2026)
- K252718: Lunar Astra (Apr 20, 2026)
- K254161: Automated Aortic Stenosis Software (AutoAS) (Mar 27, 2026)
- K221148: Vivid iq (Jul 18, 2022)
- K203677: ViewPoint 6 (Jan 15, 2021)
- K200158: Logiq E10 (Apr 17, 2020)
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (Sep 19, 2019)
- K181934: Vivid T8, Vivid T9 (Nov 6, 2018)

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