Cleared Traditional

K953095 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K953095 · Philips Medical Systems, Inc. · Radiology device

Nov 1995

Decision

134d

Days

Class 2

Risk

K953095 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 November 14, 1995, 134 days after receiving the submission on July 3, 1995.

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

Submission Details

510(k) Number	K953095 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 03, 1995
Decision Date	November 14, 1995
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF