# K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 17, 2009 after 112 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: 12 generations back to K935595 (1995). 95 ancestors in all.
569 later devices descend from it; 10 cite it directly.
0 of 665 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 1.
- K081921: GE Vivid E9 Ultrasound, General Electric Co. (2008) Summary page 1.
- K083095: Sonixtouch Ultrasound System, Ultrasonix Medical Corporation (2008) Summary page 1.

## Most influential descendants
- K110943: Logiq E9 (2011), 472 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own
- K111582: Logiq S8 (2011), 367 descendants of its own
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2983-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

## 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 Introoperative (abdominal, thoracic, vascular and neurosurgical).

Source page: https://510kreport.com/device/K092271
Methodology: https://510kreport.com/methodology