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FDA 510(k)

Synapse PACS (7.5)

K-Number: K243647 · 2025-06-30

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2025-06-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse PACS (7.5) is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2025-06-30 under approval number K243647. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synapse PACS (7.5)?

Synapse PACS (7.5) is a medical device that received FDA 510(k) clearance on 2025-06-30. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K243647.

When was Synapse PACS (7.5) approved by the FDA?

Synapse PACS (7.5) received FDA 510(k) clearance on 2025-06-30, under approval number K243647.

What company makes Synapse PACS (7.5)?

Synapse PACS (7.5) is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Synapse PACS (7.5)?

The FDA product code for Synapse PACS (7.5) is QIH.

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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.

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