Cleared Traditional

K961140 - FLUOROPLUS CARDIAC TV

K961140 is an FDA 510(k) clearance for FLUOROPLUS CARDIAC TV, manufactured by Cmt Medical Technologies, Ltd.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K961140

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
Combination Product No
PCCP Authorized No
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.

JAA Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K961140.
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