510(k) K070390

FLUOROPRO RF DIGITAL IMAGING SYSTEM by Virtual Imaging, Inc. — Product Code JAA

K070390 is an FDA 510(k) premarket notification submitted by Virtual Imaging, Inc. for the device "FLUOROPRO RF DIGITAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2007. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), 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
April 5, 2007
Date Received
February 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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