# K133533: Logiq E

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 12, 2014 after 86 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 131 ancestors in all.
149 later devices descend from it; 2 cite it directly.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 1.
- K131527: Logiq S8, GE Healthcare (2013) Summary page 1.
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 2.
- K120741: Voluson S6, Voluson S8, GE Healthcare (2012) Summary page 1.

## Most influential descendants
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own
- K151028: LOGIQ e (2015), 60 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K152195: Logiq S8 (2015), 57 descendants of its own

## Indications for use
The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).

Source page: https://510kreport.com/device/K133533
Methodology: https://510kreport.com/methodology