FDA 510(k)

Sirona Advanced Imaging Suite

K-Number: K251030 · 2025-10-22

Decision Date2025-10-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Sirona Advanced Imaging Suite is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Medical. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251030. 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 Sirona Advanced Imaging Suite?

Sirona Advanced Imaging Suite is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Sirona Medical. The 510(k) number is K251030.

When did Sirona Advanced Imaging Suite receive FDA 510(k) clearance?

Sirona Advanced Imaging Suite received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251030.

Who is the listed applicant for Sirona Advanced Imaging Suite?

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

What is the FDA product code for Sirona Advanced Imaging Suite?

The FDA product code for Sirona Advanced Imaging Suite 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.