510(k) K210682

SOTA Cloud Imaging by Sota Precision Optics, Inc. Dba Sota Imaging — Product Code LLZ

K210682 is an FDA 510(k) premarket notification submitted by Sota Precision Optics, Inc. Dba Sota Imaging for the device "SOTA Cloud Imaging". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Sota Precision Optics, Inc. Dba Sota Imaging has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
Mar 8, 2021
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
510(k)