# K191792: Versana Balance

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Aug 9, 2019 after 37 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: 25 generations back to K935595 (1995). 277 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182277: Versana Premier, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 6.
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 6.
- K181727: Vivid iq, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 17.
- K183362: Venue GO, GE Medical Systems Ultrasound and Primary Care Diagnostics (2019) Summary page 6.
- K181783: Logiq P9; Logiq P7, GE Healthcare (2018) Summary page 6.

## Most influential descendants
- K220446: Versana Balance (2022), 1 descendant of its own
- K223407: Versana Essential (2023), 0 descendants of its own
- K200998: Versana Active (2020), 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 (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.

Source page: https://510kreport.com/device/K191792
Methodology: https://510kreport.com/methodology