# Ge Medical Systems Ultrasound and Primary Care Dia

- Location (FDA's records): Madison, WI
- FDA decisions: 7 (2004–2011): 7 510(k) clearances
- Product codes: KGI (4), IYN (2), IYO (1)
- Predicates its devices cite: 26 (2 its own); citations of its devices by later devices: 15 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lunar Corp.: 12 (https://510kreport.com/company/lunar)
- Ge Lunar Corp.: 5 (https://510kreport.com/company/ge-lunar)
- General Electric Co.: 5 (https://510kreport.com/company/general-electric)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Ge Medical Systems Lunar: 1 (https://510kreport.com/company/ge-medical-systems-lunar)

## Firms that cite its devices most
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 2 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)
- Ultrasonix Medical Corporation: 1 (https://510kreport.com/company/ultrasonix-medical)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Civco: 1 (https://510kreport.com/company/civco)
- Osyris Medical: 1 (https://510kreport.com/company/osyris-medical)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)

## Its most-cited devices
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 (2008), cited by 8
- K041813: GE Logiq 7 Ultrasound BT04 (2004), cited by 2
- K072664: GE Lunar Femur Strength Software (2008), cited by 2
- K052581: Lunar Idxa (2005), cited by 1
- K103730: GE Lunar Visceral Fat Software (2011), cited by 1
- K073408: GE Logiq BT08 Diagnostic Ultrasound System (2007), cited by 1

## Recent decisions
- K103730: GE Lunar Visceral Fat Software (May 6, 2011)
- K072664: GE Lunar Femur Strength Software (Nov 21, 2008)
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 (Aug 15, 2008)
- K073408: GE Logiq BT08 Diagnostic Ultrasound System (Dec 19, 2007)
- K072439: GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit (Sep 14, 2007)
- K052581: Lunar Idxa (Oct 20, 2005)
- K041813: GE Logiq 7 Ultrasound BT04 (Jul 23, 2004)

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