510(k) K241524

Elucid PlaqueIQ by Elucid Bioimaging, Inc. — Product Code LLZ

K241524 is an FDA 510(k) premarket notification submitted by Elucid Bioimaging, Inc. for the device "Elucid PlaqueIQ". The FDA issued a decision of Substantially Equivalent on September 12, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Elucid Bioimaging, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2024
Date Received
May 29, 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