# K261313: Vivid Explorer/Vivid Advanced/Vivid Focus

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Sep 2, 2026 after 134 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: 28 generations back to K935595 (1995). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223832: Vivid S60N, Vivid S70N, Ge Medical System Ultrasound and Primary Care Diagnostics (2023) Summary page 6.

## Indications for use
Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid Explorer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/ 4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. Vivid Advanced is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. Vivid Focus is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room and Cath lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Source page: https://510kreport.com/device/K261313
Methodology: https://510kreport.com/methodology