Cleared Traditional

K024147 - PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM (FDA 510(k) Clearance)

K024147 · Varian Medical Systems, Inc. · Radiology device

Feb 2003

Decision

58d

Days

Class 2

Risk

K024147 is an FDA 510(k) clearance for the PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 12, 2003, 58 days after receiving the submission on December 16, 2002.

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

Submission Details

510(k) Number	K024147 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 2002
Decision Date	February 12, 2003
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF