Cleared Traditional

PANORAMA 1.0T

K041602 · Philips Medical Systems North America, Inc. · Radiology
Jul 2004
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K041602 is an FDA 510(k) clearance for the PANORAMA 1.0T, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Philips Medical Systems North America, Inc. (Bothell, US). The FDA issued a Cleared decision on July 26, 2004, 42 days after receiving the submission on June 14, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K041602 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2004
Decision Date July 26, 2004
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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