510(k) K070563

VIDAR VISION 2000 by Vidar Systems Corp. — Product Code MQB

K070563 is an FDA 510(k) premarket notification submitted by Vidar Systems Corp. for the device "VIDAR VISION 2000". The FDA issued a decision of Substantially Equivalent on March 16, 2007. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Vidar Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2007
Date Received
February 27, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type