Cleared Traditional

CARBON FIBER CONFORMAL COUCH TOP

K973842 · Medtec, Inc. · Radiology
Dec 1997
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K973842 is an FDA 510(k) clearance for the CARBON FIBER CONFORMAL COUCH TOP, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 5, 1997, 58 days after receiving the submission on October 8, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K973842 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1997
Decision Date December 05, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXQ — Table, Radiographic, Stationary Top
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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