CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

FDA 510(k) K253831 · Cercare Medical A/S

Substantially Equivalent

510(k) numberK253831

Submission

Device name
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
Applicant
Cercare Medical A/S
Aarhus C, DK
Received
December 1, 2025
Decision date
May 18, 2026
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

Other 510(k)s with product code LLZ

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K260316CMN Capillary Function with Oncology Virtual ExpertQIH · Traditional 06/22/2026SE
K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertLLZ · Traditional 12/06/2024SE
K230016Cercare Medical NeurosuiteLLZ · Traditional 07/14/2023SE

Questions and answers

When was CMN Capillary Function with Virtual Expert for MRI, CT and CBCT cleared by the FDA?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (K253831) received a 510(k) decision of Substantially Equivalent on May 18, 2026, 168 days after the submission was received.

What is the product code of K253831?

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