Cleared Traditional

K972103 - PHILIPS EASYVISION (FDA 510(k) Clearance)

K972103 · Philips Medical Systems North America, Inc. · Radiology device

Sep 1997

Decision

90d

Days

Class 2

Risk

K972103 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 September 2, 1997, 90 days after receiving the submission on June 4, 1997.

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

Submission Details

510(k) Number	K972103 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 1997
Decision Date	September 02, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF