Cleared Traditional

B-400 CEILING MOUNTED POSSITIONER, MODEL B-400

K990055 · Omega Medical Imaging, Inc. · Radiology
Feb 1999
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K990055 is an FDA 510(k) clearance for the B-400 CEILING MOUNTED POSSITIONER, MODEL B-400, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Omega Medical Imaging, Inc. (Sanford, US). The FDA issued a Cleared decision on February 2, 1999, 26 days after receiving the submission on January 7, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K990055 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1999
Decision Date February 02, 1999
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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