Cleared Traditional

INTEGRA IMMOBILIZATION SYSTEM

K050888 · Diacor, Inc. · Radiology
May 2005
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K050888 is an FDA 510(k) clearance for the INTEGRA IMMOBILIZATION SYSTEM, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 23, 2005, 46 days after receiving the submission on April 7, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K050888 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2005
Decision Date May 23, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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