# K110943: Logiq E9

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jul 22, 2011 after 109 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 96 ancestors in all.
472 later devices descend from it; 4 cite it directly.
0 of 569 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 1.
- K052441: GE Logiq 7 Ultrasound BT05, General Electric Co. (2005) Summary page 1.

## Most influential descendants
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own
- K120741: Voluson S6, Voluson S8 (2012), 295 descendants of its own
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2983-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
- Jan 3, 2012 · Not classified · Z-0705-2012: GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 - User may notice an image from a different patie

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracie, vascular and neurosurgical).

Source page: https://510kreport.com/device/K110943
Methodology: https://510kreport.com/methodology