510(k) K090649

VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE by Virtual Radiologic Corporation — Product Code LLZ

K090649 is an FDA 510(k) premarket notification submitted by Virtual Radiologic Corporation for the device "VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on March 27, 2009. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Virtual Radiologic Corporation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2009
Date Received
March 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type