# K101324: GE Echopac Model BT10

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Oct 5, 2010 after 147 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: 6 generations back to K003931 (2001). 11 ancestors in all.
172 later devices descend from it; 2 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072952: GE Echopac, General Electric Co. (2007) Summary page 1.
- K081921: GE Vivid E9 Ultrasound, General Electric Co. (2008) Summary page 1.
- K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound, Ge Medical Systems Israel, Ultrasound, Ltd. (2009) Summary page 1.

## Most influential descendants
- 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
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (2014), 84 descendants of its own

## Indications for use
The GE EchoPAC BT10 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); Musculoskeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K101324
Methodology: https://510kreport.com/methodology