Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sirona Advanced Imaging Suite

K-Number: K251030 · 2025-10-22

ApplicantSirona Medical
Decision Date2025-10-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sirona Advanced Imaging Suite is a medical device manufactured by Sirona Medical. It received FDA 510(k) clearance on 2025-10-22 under approval 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. It is manufactured by Sirona Medical. The 510(k) number is K251030.

When was Sirona Advanced Imaging Suite approved by the FDA?

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

What company makes Sirona Advanced Imaging Suite?

Sirona Advanced Imaging Suite is manufactured by Sirona Medical.

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

The FDA product code for Sirona Advanced Imaging Suite is LLZ.

Related Clinical Trials

NCT04595474 Prevalence of NAFLD and Advanced Fibrosis in Patients With Type 1 Diabetes ACTIVE_NOT_RECRUITING NCT07592611 Deep Brain Stimulation for Treatment-Resistant Schizophrenia NOT_YET_RECRUITING NCT02361554 Deep Brain Stimulation in Treatment Resistant Schizophrenia TERMINATED NCT01036581 Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging RECRUITING NCT04975139 Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks ACTIVE_NOT_RECRUITING NCT06116253 Advanced Diffusion Imaging in Renal Cancer Patients ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 28584684 Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA. Journal of pathology informatics (2017)

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑