510(k) K253950

Avatar Medical Vision by Avatar Medical — Product Code LLZ

K253950 is an FDA 510(k) premarket notification submitted by Avatar Medical for the device "Avatar Medical Vision". The FDA issued a decision of Substantially Equivalent on Mar 30, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Avatar Medical has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 2026
Date Received
Dec 10, 2025
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