Cleared Traditional

PHILIPS ORTHOPAEDIC APPLICATIONS

K042867 · Philips Medical Systems North America, Inc. · Radiology
Nov 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K042867 is an FDA 510(k) clearance for the PHILIPS ORTHOPAEDIC APPLICATIONS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Philips Medical Systems North America, Inc. (Bothell, US). The FDA issued a Cleared decision on November 2, 2004, 15 days after receiving the submission on October 18, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K042867 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2004
Decision Date November 02, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050