# K122114: Logiq S7 Expert, Logiq S7 Pro

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 3, 2012 after 78 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: 15 generations back to K935595 (1995). 115 ancestors in all.
220 later devices descend from it; 2 cite it directly.
0 of 336 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 11.
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 1.
- K101874: GE Logiq P6/P6 Pro, GE Healthcare (2010) Summary page 1.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 1.
- K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System, GE Healthcare (2011) Summary page 1.

## Most influential descendants
- K131527: Logiq S8 (2013), 219 descendants of its own
- 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

## Recalls of this device
- Feb 8, 2013 · Class II · Z-1096-2013: GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this i

## 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 and Intraoperative (abdominal, thoracic, vascular-and neurosurgical).

Source page: https://510kreport.com/device/K122114
Methodology: https://510kreport.com/methodology