Cleared Traditional

K920950 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K920950 · Philips Medical Systems, Inc. · Radiology device

Apr 1992

Decision

61d

Days

Class 2

Risk

K920950 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. (5680 Da Best, NL). The FDA issued a Cleared decision on April 27, 1992, 61 days after receiving the submission on February 26, 1992.

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

Submission Details

510(k) Number	K920950 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 26, 1992
Decision Date	April 27, 1992
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF