# K181727: Vivid iq

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Dec 6, 2018 after 160 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: 24 generations back to K935595 (1995). 273 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161706: Vivid iq, Ge Medical Systems Ultrasound and Primary Care Diagnostics L (2016) Summary page 5.
- K170823: Vivid E80, Vivid E90, Vivid E95, GE Medical Systems Ultrasound and Primary Care Diagnostics (2017) Summary page 27.
- K180599: Venue, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 27.
- K161588: Vscan Extend, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 27.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 5.
- K160078: Vivid T8, Ge Medical Systems Ultrasound and Primary Care Diagnotics, L (2016) Summary page 5.
- K163596: LOGIQ P9 and LOGIQ P7, GE Healthcare (2017) Summary page 5.

## Most influential descendants
- K200708: Vivid iq (2020), 3 descendants of its own
- K191792: Versana Balance (2019), 3 descendants of its own
- K221148: Vivid iq (2022), 2 descendants of its own
- K220446: Versana Balance (2022), 1 descendant of its own
- K191798: Versana Active (2019), 1 descendant of its own

## Indications for use
The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

Source page: https://510kreport.com/device/K181727
Methodology: https://510kreport.com/methodology