# K173555: Logiq E10

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Dec 20, 2017 after 33 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: 19 generations back to K935595 (1995). 151 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2016) Summary page 7.

## Most influential descendants
- K181985: Voluson E6, Voluson E8, Voluson E10 (2018), 17 descendants of its own
- K200158: Logiq E10 (2020), 12 descendants of its own
- K211488: Logiq E10 (2021), 11 descendants of its own
- K192505: HS50/HS60 Diagnostics Ultrasound System (2019), 10 descendants of its own
- K200119: LOGIQ E10s (2020), 9 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.
- Sep 14, 2018 · Class II · Z-0588-2019: There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.

## 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 (vascular).

Source page: https://510kreport.com/device/K173555
Methodology: https://510kreport.com/methodology