510(k) K021372

VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY by J. Morita USA, Inc. — Product Code EAG

K021372 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY". The FDA issued a decision of Substantially Equivalent on June 7, 2002. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2002
Date Received
April 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type