Cleared Traditional

B-350 CEILING MOUNTED C-POSITIONER

K970947 · Omega Medical Imaging, Inc. · Radiology
May 1997
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K970947 is an FDA 510(k) clearance for the B-350 CEILING MOUNTED C-POSITIONER, 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 May 14, 1997, 61 days after receiving the submission on March 14, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K970947 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1997
Decision Date May 14, 1997
Days to Decision 61 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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