Cleared Traditional

MED-TEC REDISET

K952189 · Medtec, Inc. · Radiology
Aug 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K952189 is an FDA 510(k) clearance for the MED-TEC REDISET, 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 August 9, 1995, 92 days after receiving the submission on May 9, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K952189 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1995
Decision Date August 09, 1995
Days to Decision 92 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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