Cleared Special

K060941 - CAAS MRV VERSION 3.0 (FDA 510(k) Clearance)

K060941 · Pie Medical Imaging BV · Radiology device

Apr 2006

Decision

13d

Days

Class 2

Risk

K060941 is an FDA 510(k) clearance for the CAAS MRV VERSION 3.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Pie Medical Imaging BV (Eden Prairie, US). The FDA issued a Cleared decision on April 19, 2006, 13 days after receiving the submission on April 6, 2006.

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

Submission Details

510(k) Number	K060941 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2006
Decision Date	April 19, 2006
Days to Decision	13 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF