Cleared Traditional

K963980 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K963980 · Philips Medical Systems North America, Inc. · Radiology device

Dec 1996

Decision

81d

Days

Class 2

Risk

K963980 is an FDA 510(k) clearance for the PHILIPS EASYVISION. 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 December 23, 1996, 81 days after receiving the submission on October 3, 1996.

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

Submission Details

510(k) Number	K963980 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 03, 1996
Decision Date	December 23, 1996
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF