# K131527: Logiq S8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 26, 2013 after 90 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: 16 generations back to K935595 (1995). 120 ancestors in all.
219 later devices descend from it; 6 cite it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111582: Logiq S8, GE Healthcare (2011) Summary page 1.
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 1.
- K122114: Logiq S7 Expert, Logiq S7 Pro, GE Healthcare (2012) Summary page 1.
- K101149: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K013690: Ident-A100 Intraoral Video Camera, Confident Technology, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133034: Logiq F Series (2014), 155 descendants of its own
- K133533: Logiq E (2014), 149 descendants of its own
- K141261: Logiq S7 Expert, Logiq S7 Pro (2014), 144 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own

## 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, vascular and neurosurgical).

Source page: https://510kreport.com/device/K131527
Methodology: https://510kreport.com/methodology