Synapse PACS
K-Number: K190232 · 2019-03-26
ApplicantFujifilm Corporation
Decision Date2019-03-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Synapse PACS is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-03-26 under approval number K190232. 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 2019-03-26. It is manufactured by Fujifilm Corporation. The 510(k) number is K190232.
When was Synapse PACS approved by the FDA?
Synapse PACS received FDA 510(k) clearance on 2019-03-26, under approval number K190232.
What company makes Synapse PACS?
Synapse PACS is manufactured by Fujifilm Corporation.
What is the FDA product code for Synapse PACS?
The FDA product code for Synapse PACS is LLZ.
Other Devices by Fujifilm Corporation
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.