510(k) K092439

CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF by Virtual Imaging, Inc. — Product Code OWB

K092439 is an FDA 510(k) premarket notification submitted by Virtual Imaging, Inc. for the device "CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF". The FDA issued a decision of Substantially Equivalent on November 30, 2009. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Virtual Imaging, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2009
Date Received
August 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy