# K160406: FUJIFILM FC1 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Mar 16, 2016 after 29 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: 12 generations back to K945773 (1995). 54 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133454: Sonosite Edge Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 14.
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System, FUJIFILM Sonosite, Inc. (2015) Summary page 14.

## Most influential descendants
- K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System (2016), 11 descendants of its own
- K171437: SonoSite X-Porte Ultrasound System (2017), 7 descendants of its own
- K200964: Sonosite PX Ultrasound System (2020), 6 descendants of its own
- K213763: Sonosite PX Ultrasound System (2021), 4 descendants of its own
- K233597: Sonosite LX Ultrasound System (2023), 3 descendants of its own

## Indications for use
The FUJIFILM FC1Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Source page: https://510kreport.com/device/K160406
Methodology: https://510kreport.com/methodology