Cleared Traditional

K032096 - PHILIPS VIEWFORUM 2003 (FDA 510(k) Clearance)

K032096 · Philips Medical Systems · Radiology device

Jul 2003

Decision

10d

Days

Class 2

Risk

K032096 is an FDA 510(k) clearance for the PHILIPS VIEWFORUM 2003. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on July 18, 2003, 10 days after receiving the submission on July 8, 2003.

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

Submission Details

510(k) Number	K032096 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 08, 2003
Decision Date	July 18, 2003
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF