Cleared Traditional

K090672 - AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS (FDA 510(k) Clearance)

K090672 · Agfa Healthcare N.V. · Radiology device

May 2009

Decision

66d

Days

Class 2

Risk

K090672 is an FDA 510(k) clearance for the AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).

Submitted by Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on May 18, 2009, 66 days after receiving the submission on March 13, 2009.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K090672 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 13, 2009
Decision Date	May 18, 2009
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF