Cleared Traditional

PHILIPS EASY DIAGNOST

K970640 · Philips Medical Systems North America, Inc. · Radiology
Mar 1997
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K970640 is an FDA 510(k) clearance for the PHILIPS EASY DIAGNOST, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on March 21, 1997, 29 days after receiving the submission on February 20, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K970640 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 1997
Decision Date March 21, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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