FDA 510(k)

Syneris PACS v.1.0.1.0

K-Number: K261874 · 2026-09-23

Decision Date2026-09-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Syneris PACS v.1.0.1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Syneris. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K261874. 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 Syneris PACS v.1.0.1.0?

Syneris PACS v.1.0.1.0 is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Syneris. The 510(k) number is K261874.

When did Syneris PACS v.1.0.1.0 receive FDA 510(k) clearance?

Syneris PACS v.1.0.1.0 received FDA 510(k) clearance on 2026-09-23, under 510(k) number K261874.

Who is the listed applicant for Syneris PACS v.1.0.1.0?

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

What is the FDA product code for Syneris PACS v.1.0.1.0?

The FDA product code for Syneris PACS v.1.0.1.0 is LLZ.

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.