510(k) K091866

PROGENY VANTAGE PANORAMIC X-RAY SYSTEM by Midmark — Product Code MUH

K091866 is an FDA 510(k) premarket notification submitted by Midmark for the device "PROGENY VANTAGE PANORAMIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 2009. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Midmark has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2009
Date Received
June 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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