510(k) K853983

CANON X-RAY 35MM CINE CAMERA CSI-35 by Canon USA, Inc. — Product Code IZJ

K853983 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON X-RAY 35MM CINE CAMERA CSI-35". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type