510(k) K241989

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert by Cercare Medical A/S — Product Code LLZ

K241989 is an FDA 510(k) premarket notification submitted by Cercare Medical A/S for the device "Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert". The FDA issued a decision of Substantially Equivalent on Dec 6, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Cercare Medical A/S has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 6, 2024
Date Received
Jul 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type