# K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Sep 14, 2015 after 31 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: 17 generations back to K935595 (1995). 149 ancestors in all.
100 later devices descend from it; 4 cite it directly.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 39.
- K131527: Logiq S8, GE Healthcare (2013) Summary page 38.
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2013) Summary page 39.

## Most influential descendants
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2016), 73 descendants of its own
- K162269: Voluson E6, Voluson E8, Voluson E10 (2016), 41 descendants of its own
- K173555: Logiq E10 (2017), 38 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (2018), 21 descendants of its own

## Recalls of this device
- Jul 2, 2019 · Class II · Z-1964-2019: Potential for a transducer mis-alignment in certain transvaginal probes.

## 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/K152309
Methodology: https://510kreport.com/methodology