510(k) K202664

Clio Prime and Clio Pedo by Sota Precision Optics, Inc. Dba Sota Imaging — Product Code MUH

K202664 is an FDA 510(k) premarket notification submitted by Sota Precision Optics, Inc. Dba Sota Imaging for the device "Clio Prime and Clio Pedo". The FDA issued a decision of Substantially Equivalent on Nov 6, 2020. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Sota Precision Optics, Inc. Dba Sota Imaging has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 6, 2020
Date Received
Sep 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type
510(k)