# K061129: GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jun 1, 2006 after 38 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011188 (2001). 4 ancestors in all.
430 later devices descend from it; 5 cite it directly.
0 of 435 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011188: GE Logiq 9, Model 2188900-X, GE Medical Systems (2001)
- K030934: GE Logiq 9 Model 2375600, Ge Medical Systems, Inc. (2003) Summary page 1.
- K032656: GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X, Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc (2003) Summary page 1.
- K040251: GE Logiq 9 Diagnostic Ultrasound System, Model 2404587, Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc (2004)
- (no number) GE Logiq 7: named in the summary without a submission number

## Most influential descendants
- K082098: Sonosite Maxx Series Ultrasound System (2008), 247 descendants of its own
- K113156: Sonosite Edge Ultrasound System (2011), 216 descendants of its own
- K072164: DC-6 Diagnostic Ultrasound System (2007), 188 descendants of its own
- K080640: M5 Diagnostic Ultrasound System (2008), 182 descendants of its own
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2984-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K061129
Methodology: https://510kreport.com/methodology