# K142160: Logiq E9 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 10, 2014 after 65 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: 16 generations back to K935595 (1995). 129 ancestors in all.
263 later devices descend from it; 10 cite it directly.
0 of 393 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 34.
- K132274: Aixplorer, Supersonic Imagine (2013) Summary page 34.

## Most influential descendants
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 descendants of its own
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2016), 73 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 and vascular).

Source page: https://510kreport.com/device/K142160
Methodology: https://510kreport.com/methodology