Cleared Traditional

K990455 - PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION (FDA 510(k) Clearance)

K990455 · Philips Medical Systems, Inc. · Radiology device

May 1999

Decision

89d

Days

Class 2

Risk

K990455 is an FDA 510(k) clearance for the PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION. 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 May 12, 1999, 89 days after receiving the submission on February 12, 1999.

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

Submission Details

510(k) Number	K990455 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 12, 1999
Decision Date	May 12, 1999
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF