Cleared Traditional

K974207 - PHILIPS EASYVISION WORKSTATION (FDA 510(k) Clearance)

K974207 · Philips Medical Systems North America, Inc. · Radiology device

Jan 1998

Decision

73d

Days

Class 2

Risk

K974207 is an FDA 510(k) clearance for the PHILIPS EASYVISION WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on January 22, 1998, 73 days after receiving the submission on November 10, 1997.

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

Submission Details

510(k) Number	K974207 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 10, 1997
Decision Date	January 22, 1998
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF