# K170445: Logiq S8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 11, 2017 after 56 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: 21 generations back to K935595 (1995). 217 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152195: Logiq S8, GE Healthcare (2015) Summary page 41.
- K160524: FibroScan 530 Compact, Echosens (2016) Summary page 41.

## Most influential descendants
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own
- K201972: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (2020), 7 descendants of its own
- K212333: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 (2022), 6 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/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/K170445
Methodology: https://510kreport.com/methodology