Cleared Traditional

K973835 - PHILIPS EASYVISION WORKSTATION (FDA 510(k) Clearance)

K973835 · Philips Medical Systems, Inc. · Radiology device

Jan 1998

Decision

90d

Days

Class 2

Risk

K973835 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, Inc. (Shelton, US). The FDA issued a Cleared decision on January 6, 1998, 90 days after receiving the submission on October 8, 1997.

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

Submission Details

510(k) Number	K973835 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 08, 1997
Decision Date	January 06, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF