Cleared Traditional

FLUOROPLUS CARDIAC TV

K961140 · Cmt Medical Technologies, Ltd. · Radiology
Sep 1996
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K961140 is an FDA 510(k) clearance for the FLUOROPLUS CARDIAC TV, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on September 20, 1996, 183 days after receiving the submission on March 21, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K961140 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1996
Decision Date September 20, 1996
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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