Cleared Traditional

K961140 - FLUOROPLUS CARDIAC TV

K961140 is the FDA 510(k) clearance for FLUOROPLUS CARDIAC TV by Cmt Medical Technologies, Ltd.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

K961140 is an FDA 510(k) clearance for the FLUOROPLUS CARDIAC TV. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on September 20, 1996 after a review of 183 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cmt Medical Technologies, Ltd. devices

Submission Details

510(k) Number K961140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 133
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K961140.
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