Cleared Traditional

K941917 - FLUOROPLUA CARDIAC AND/OR INSTAVIEW

K941917 is an FDA 510(k) clearance for FLUOROPLUA CARDIAC AND/OR INSTAVIEW, manufactured by Fidelity Medical, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K941917 · Fidelity Medical, Inc. · Radiology device
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Feb 1995
Decision
311d
Days
Class 2
Risk

K941917 is an FDA 510(k) clearance for the FLUOROPLUA CARDIAC AND/OR INSTAVIEW. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Fidelity Medical, Inc. (Florham Park, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Fidelity Medical, Inc. devices

FDA 510(k) Submission Details - K941917

510(k) Number K941917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date February 24, 1995
Days to Decision 311 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
204d slower than avg
Panel avg: 107d · This submission: 311d
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 164
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