Cleared Traditional

K983821 - PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE (FDA 510(k) Clearance)

K983821 · Philips Medical Systems North America, Inc. · Radiology device

Dec 1998

Decision

43d

Days

Class 2

Risk

K983821 is an FDA 510(k) clearance for the PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE. 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 December 11, 1998, 43 days after receiving the submission on October 29, 1998.

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

Submission Details

510(k) Number	K983821 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 29, 1998
Decision Date	December 11, 1998
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF