Cleared Traditional

K973983 - PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D (FDA 510(k) Clearance)

K973983 · Philips Medical Systems, Inc. · Radiology device

Jan 1998

Decision

80d

Days

Class 2

Risk

K973983 is an FDA 510(k) clearance for the PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D. 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 8, 1998, 80 days after receiving the submission on October 20, 1997.

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

Submission Details

510(k) Number	K973983 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 1997
Decision Date	January 08, 1998
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF