Cleared Traditional

K023137 - PHILIPS EASYVISION WORKSTATION RELEASE 6 (FDA 510(k) Clearance)

K023137 · Philips Medical Systems North America Co. · Radiology device

Dec 2002

Decision

90d

Days

Class 2

Risk

K023137 is an FDA 510(k) clearance for the PHILIPS EASYVISION WORKSTATION RELEASE 6. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on December 19, 2002, 90 days after receiving the submission on September 20, 2002.

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

Submission Details

510(k) Number	K023137 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 2002
Decision Date	December 19, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF