Cleared Traditional

K090649 - VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE (FDA 510(k) Clearance)

K090649 · Virtual Radiologic Corporation · Radiology device

Mar 2009

Decision

16d

Days

Class 2

Risk

K090649 is an FDA 510(k) clearance for the VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Virtual Radiologic Corporation (Eden Prairie, US). The FDA issued a Cleared decision on March 27, 2009, 16 days after receiving the submission on March 11, 2009.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K090649 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 2009
Decision Date	March 27, 2009
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF