Cleared Traditional

ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT

K032156 · Wfr/Aquaplast Corp. · Radiology
Sep 2003
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K032156 is an FDA 510(k) clearance for the ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on September 2, 2003, 50 days after receiving the submission on July 14, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K032156 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2003
Decision Date September 02, 2003
Days to Decision 50 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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