Cleared Traditional

K971965 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K971965 · Philips Medical Systems, Inc. · Radiology device

Jan 1998

Decision

247d

Days

Class 2

Risk

K971965 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, Inc. (Shelton, US). The FDA issued a Cleared decision on January 30, 1998, 247 days after receiving the submission on May 28, 1997.

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

Submission Details

510(k) Number	K971965 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 28, 1997
Decision Date	January 30, 1998
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF