Cleared Traditional

K953911 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K953911 · Philips Medical Systems, Inc. · Radiology device

Jun 1996

Decision

311d

Days

Class 2

Risk

K953911 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 June 27, 1996, 311 days after receiving the submission on August 21, 1995.

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

Submission Details

510(k) Number	K953911 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 21, 1995
Decision Date	June 27, 1996
Days to Decision	311 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF