# K072952: GE Echopac

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Nov 16, 2007 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003931 (2001). 5 ancestors in all.
173 later devices descend from it; 1 cites it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K101324: GE Echopac Model BT10 (2010), 172 descendants of its own
- K120221: GE Echopac (2012), 170 descendants of its own
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 descendants of its own
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K141093: 6VT-D Ultrasound Transducer (2014), 85 descendants of its own

## Indications for use
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K072952
Methodology: https://510kreport.com/methodology