# K111582: Logiq S8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jul 26, 2011 after 50 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 96 ancestors in all.
367 later devices descend from it; 3 cite it directly.
0 of 464 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 1.
- K052441: GE Logiq 7 Ultrasound BT05, General Electric Co. (2005) Summary page 1.

## Most influential descendants
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 (2013), 255 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
- Aug 13, 2012 · Class II · Z-1944-2013: GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the s
- Feb 7, 2012 · Not classified · Z-1093-2012: GE Healthcare has become aware of a potential safety issue where an image from a different patient, or an image from the current patient with title information from a different patient maybe noticed.

## 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/K111582
Methodology: https://510kreport.com/methodology