Cleared Traditional

K040254 - INTEGRIS 3D-RA, RELEASE 4.2 (FDA 510(k) Clearance)

K040254 · Philips Medical Systems North America Co. · Radiology device

Feb 2004

Decision

15d

Days

Class 2

Risk

K040254 is an FDA 510(k) clearance for the INTEGRIS 3D-RA, RELEASE 4.2. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on February 19, 2004, 15 days after receiving the submission on February 4, 2004.

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

Submission Details

510(k) Number	K040254 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 2004
Decision Date	February 19, 2004
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF