# K182277: Versana Premier

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Nov 21, 2018 after 91 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: 22 generations back to K935595 (1995). 196 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6, GE Medical Systems Ultrasound and Primary Care Diagnostics (2016) Summary page 6.
- K163596: LOGIQ P9 and LOGIQ P7, GE Healthcare (2017) Summary page 6.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 6.
- K161706: Vivid iq, Ge Medical Systems Ultrasound and Primary Care Diagnostics L (2016) Summary page 6.
- K160078: Vivid T8, Ge Medical Systems Ultrasound and Primary Care Diagnotics, L (2016) Summary page 6.

## Most influential descendants
- K191792: Versana Balance (2019), 3 descendants of its own
- K200138: Versana Premier (2020), 2 descendants of its own
- K220446: Versana Balance (2022), 1 descendant of its own
- K210438: Versana Premier (2021), 1 descendant of its own
- K191798: Versana Active (2019), 1 descendant of its own

## Indications for use
The Versana Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Peripheral Vascular, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transrectal, Transvaginal, Tissue Biopsy/Fluid Drainage.

Source page: https://510kreport.com/device/K182277
Methodology: https://510kreport.com/methodology