510(k) K123419

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM by Afp Imaging Corp. — Product Code MUH

K123419 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "EVA SELECT DIGITAL DENTAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 2012. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2012
Date Received
November 6, 2012
Clearance Type
Special
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