# K152195: Logiq S8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 29, 2015 after 55 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: 20 generations back to K935595 (1995). 169 ancestors in all.
57 later devices descend from it; 2 cite it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131527: Logiq S8, GE Healthcare (2013) Summary page 34.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 26.
- K141261: Logiq S7 Expert, Logiq S7 Pro, GE Healthcare (2014) Summary page 28.
- K143452: Logiq P9, Logiq P7, GE Healthcare (2015) Summary page 29.
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2013) Summary page 34.

## Most influential descendants
- K160182: LOGIQ S7 Expert (2016), 36 descendants of its own
- K180409: HS40 Diagnostic Ultrasound System (2018), 34 descendants of its own
- K181336: HS50 / HS60 Diagnostic Ultrasound System (2018), 31 descendants of its own
- K192903: RS85 Diagnostic Ultrasound System (2020), 21 descendants of its own
- K170445: Logiq S8 (2017), 19 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

Source page: https://510kreport.com/device/K152195
Methodology: https://510kreport.com/methodology