FDA 510(k)

CustoMED Viewer

K-Number: K260116 · 2026-06-03

Decision Date2026-06-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CustoMED Viewer is the device name listed in this FDA 510(k) record. The listed applicant is CustoMED , Ltd.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260116. 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 CustoMED Viewer?

CustoMED Viewer is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is CustoMED , Ltd.. The 510(k) number is K260116.

When did CustoMED Viewer receive FDA 510(k) clearance?

CustoMED Viewer received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260116.

Who is the listed applicant for CustoMED Viewer?

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

What is the FDA product code for CustoMED Viewer?

The FDA product code for CustoMED Viewer 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.