# K120221: GE Echopac

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Mar 30, 2012 after 65 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: 7 generations back to K003931 (2001). 12 ancestors in all.
170 later devices descend from it; 3 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101324: GE Echopac Model BT10, Ge Vingmed Ultrasound AS (2010) Summary page 1.

## Most influential descendants
- 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
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (2014), 84 descendants of its own
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2016), 73 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, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K120221
Methodology: https://510kreport.com/methodology