Synapse PACS
K-Number: K160108 · 2016-02-03
ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2016-02-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Synapse PACS is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-02-03 under approval number K160108. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synapse PACS?
Synapse PACS is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K160108.
When was Synapse PACS approved by the FDA?
Synapse PACS received FDA 510(k) clearance on 2016-02-03, under approval number K160108.
What company makes Synapse PACS?
Synapse PACS is manufactured by Fujifilm Medical Systems U.S.A, Inc..
What is the FDA product code for Synapse PACS?
The FDA product code for Synapse PACS is LLZ.
Other Devices by Fujifilm Medical Systems U.S.A, Inc.
Related Devices (Code: LLZ)
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.