510(k) K070248

VELOCITYAIS by Velocity Medical Solutions, LLC — Product Code LLZ

K070248 is an FDA 510(k) premarket notification submitted by Velocity Medical Solutions, LLC for the device "VELOCITYAIS". The FDA issued a decision of Substantially Equivalent on March 1, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Velocity Medical Solutions, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
January 25, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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