# K220446: Versana Balance

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: May 11, 2022 after 84 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: 26 generations back to K935595 (1995). 278 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191792: Versana Balance, GE Medical Systems Ultrasound and Primary Care Diagnostics (2019) Summary page 4.

## Most influential descendants
- K223407: Versana Essential (2023), 0 descendants of its own

## Indications for use
The Versana Balance is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color. Versana Balance is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K220446
Methodology: https://510kreport.com/methodology