# K123564: Logiq E9 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Dec 18, 2012 after 28 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: 15 generations back to K935595 (1995). 115 ancestors in all.
323 later devices descend from it; 6 cite it directly.
0 of 439 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110943: Logiq E9, GE Healthcare (2011)
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 1.
- K122327: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 1.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011)

## Most influential descendants
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own
- K131527: Logiq S8 (2013), 219 descendants of its own
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 descendants of its own
- K133034: Logiq F Series (2014), 155 descendants of its own
- K133533: Logiq E (2014), 149 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.

## 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, thoracic, vascular and neurosurgical).

Source page: https://510kreport.com/device/K123564
Methodology: https://510kreport.com/methodology