Cleared Traditional

K023440 - PHILIPS DIGITAL IMAGING OPTION RELEASE 1 (FDA 510(k) Clearance)

K023440 · Philips Medical Systems · Radiology device

Oct 2002

Decision

15d

Days

Class 2

Risk

K023440 is an FDA 510(k) clearance for the PHILIPS DIGITAL IMAGING OPTION RELEASE 1. 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 October 30, 2002, 15 days after receiving the submission on October 15, 2002.

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

Submission Details

510(k) Number	K023440 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2002
Decision Date	October 30, 2002
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF