Cleared Traditional

MATRIX MT-MX3

K974700 · Medtec, Inc. · Radiology
Mar 1998
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K974700 is an FDA 510(k) clearance for the MATRIX MT-MX3, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on March 4, 1998, 78 days after receiving the submission on December 16, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K974700 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1997
Decision Date March 04, 1998
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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