510(k) K022953

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM by Schick Technologies, Inc. — Product Code MUH

K022953 is an FDA 510(k) premarket notification submitted by Schick Technologies, Inc. for the device "MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 2, 2002. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Schick Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2002
Date Received
September 5, 2002
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