Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

FDA 510(k) K241989 · Cercare Medical A/S

Substantially Equivalent

510(k) numberK241989

Submission

Device name
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Applicant
Cercare Medical A/S
Aarhus C, DK
Received
July 8, 2024
Decision date
December 6, 2024
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 Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert cleared by the FDA?

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (K241989) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 151 days after the submission was received.

What is the product code of K241989?

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