# K160182: LOGIQ S7 Expert

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Feb 26, 2016 after 30 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). 170 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141261: Logiq S7 Expert, Logiq S7 Pro, GE Healthcare (2014) Summary page 4.
- K152195: Logiq S8, GE Healthcare (2015) Summary page 26.
- K141639: Voluson S6, Voluson S8, GE Healthcare (2014) Summary page 31.
- K143452: Logiq P9, Logiq P7, GE Healthcare (2015) Summary page 31.

## Most influential descendants
- 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
- K211945: V8 Diagnostic Ultrasound System (2021), 13 descendants of its own
- K220975: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (2022), 12 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 Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); 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).

Source page: https://510kreport.com/device/K160182
Methodology: https://510kreport.com/methodology