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FDA 510(k)

Synapse Enterprise Viewer Version 1.0

K-Number: K183248 · 2019-04-25

ApplicantFujifilm Corporation
Decision Date2019-04-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse Enterprise Viewer Version 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K183248. 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 Enterprise Viewer Version 1.0?

Synapse Enterprise Viewer Version 1.0 is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Fujifilm Corporation. The 510(k) number is K183248.

When did Synapse Enterprise Viewer Version 1.0 receive FDA 510(k) clearance?

Synapse Enterprise Viewer Version 1.0 received FDA 510(k) clearance on 2019-04-25, under 510(k) number K183248.

Who is the listed applicant for Synapse Enterprise Viewer Version 1.0?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapse Enterprise Viewer Version 1.0?

The FDA product code for Synapse Enterprise Viewer Version 1.0 is LLZ.

Other records listing Fujifilm Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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