FUJIFILM FC1 Ultrasound System
K-Number: K160406 · 2016-03-16
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-03-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FUJIFILM FC1 Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-03-16 under approval number K160406. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FUJIFILM FC1 Ultrasound System?
FUJIFILM FC1 Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K160406.
When was FUJIFILM FC1 Ultrasound System approved by the FDA?
FUJIFILM FC1 Ultrasound System received FDA 510(k) clearance on 2016-03-16, under approval number K160406.
What company makes FUJIFILM FC1 Ultrasound System?
FUJIFILM FC1 Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for FUJIFILM FC1 Ultrasound System?
The FDA product code for FUJIFILM FC1 Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.