# K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Mar 31, 2006 after 30 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: 4 generations back to K003931 (2001). 4 ancestors in all.
689 later devices descend from it; 7 cite it directly.
0 of 694 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003931: Vivid 7 with Sonopac, Model FB0008XX, Ge Medical Systems, Inc. (2001) Summary page 1.
- K031663: GE Vivid 7, Model FC0003XX, General Electric Co. (2003) Summary page 1.
- K041552: GE Vivid 7 BT04, General Electric Co. (2004) Summary page 1.
- K051449: GE Vivid 7 with or Without Suffix, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K081921: GE Vivid E9 Ultrasound (2008), 579 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

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2989-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K060542
Methodology: https://510kreport.com/methodology