# K073408: GE Logiq BT08 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
- Decided: Dec 19, 2007 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010329 (2001). 4 ancestors in all.
628 later devices descend from it; 1 cites it directly.
0 of 633 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010329: LOGIQ 500, General Electric Co. (2001) Summary page 1.
- K032182: GE Logiq 7, Model 2354858, General Electric Co. (2003) Summary page 1.
- K041813: GE Logiq 7 Ultrasound BT04, Ge Medical Systems Ultrasound and Primary Care Dia (2004) Summary page 1.
- K052441: GE Logiq 7 Ultrasound BT05, General Electric Co. (2005) Summary page 1.

## Most influential descendants
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 (2008), 627 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K073408
Methodology: https://510kreport.com/methodology