Sirona Advanced Imaging Suite

FDA 510(k) K251030 · Sirona Medical

Substantially Equivalent

510(k) numberK251030

Submission

Device name
Sirona Advanced Imaging Suite
Applicant
Sirona Medical
San Francisco, CA, US
Received
April 3, 2025
Decision date
October 22, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Sirona Advanced Imaging Suite cleared by the FDA?

Sirona Advanced Imaging Suite (K251030) received a 510(k) decision of Substantially Equivalent on October 22, 2025, 202 days after the submission was received.

What is the product code of K251030?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.