Cleared Traditional

K160406 - FUJIFILM FC1 Ultrasound System

K160406 is the FDA 510(k) clearance for FUJIFILM FC1 Ultrasound System by FUJIFILM Sonosite, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K160406 · FUJIFILM Sonosite, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
29d
Days
Class 2
Risk

K160406 is an FDA 510(k) clearance for the FUJIFILM FC1 Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on March 16, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all FUJIFILM Sonosite, Inc. devices

Submission Details

510(k) Number K160406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date March 16, 2016
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 780
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K160406.
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
K160807 · Philips Ultrasound, Inc. · Apr 2016
Acclarix LX8 Diagnostic Ultrasound System
K160790 · Edan Instruments, Inc. · Apr 2016
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
K160277 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 2016
TE7 Diagnostic Ultrasound System
K160381 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
LOGIQ S7 Expert
K160182 · Ge Healthcare · Feb 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · Ge Healthcare · Feb 2016